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    Clinical Trial Results:
    A Phase 2 interventional, multicenter, randomized open label study to determine the effective and tolerable dose of KAF156 and Lumefantrine Solid Dispersion Formulation in combination, given once daily for 1, 2 and 3-days to adults and children with uncomplicated Plasmodium falciparum malaria

    Summary
    EudraCT number
    		 2020-003284-25
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CKAF156A2202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03167242
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@Novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Jun 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to determine the effective doses of KAF156 combined with LUM-SDF given daily over 1, 2, or 3 days for treatment of uncomplicated malaria caused by P. falciparum.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Burkina Faso: 29
    Country: Number of subjects enrolled
    Côte d’Ivoire: 40
    Country: Number of subjects enrolled
    Gabon: 42
    Country: Number of subjects enrolled
    Vietnam: 41
    Country: Number of subjects enrolled
    Thailand: 7
    Country: Number of subjects enrolled
    Kenya: 137
    Country: Number of subjects enrolled
    India: 2
    Country: Number of subjects enrolled
    Mozambique: 30
    Country: Number of subjects enrolled
    Uganda: 134
    Country: Number of subjects enrolled
    Mali: 62
    Worldwide total number of subjects
    524
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    179
    Adolescents (12-17 years)
    197
    Adults (18-64 years)
    148
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were recruited from 13 sites in 10 countries.

    Pre-assignment
    Screening details
    		 Before being enrolled in the study, participants underwent a prescreening evaluation to ascertain the Plasmodium falciparum parasitemia count.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 day
    Arm description
    		 Participants received a single oral dose of KAF156 200 mg and LUM-SDF 960 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    KAF156
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with LUM-SDF once daily (QD) for 1 day at 200 mg.

    Investigational medicinal product name
    Lumefantrine Solid Dispersion Formulation
    Investigational medicinal product code
    Other name
    LUM-SDF / LUM
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with KAF156 once daily (QD) for 1 day at 960 mg.

    Arm title
    		 Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day
    Arm description
    		 Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumefantrine Solid Dispersion Formulation
    Investigational medicinal product code
    Other name
    LUM-SDF / LUM
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with KAF156 oncedaily (QD) for 1 day at 960 mg.

    Investigational medicinal product name
    KAF156
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with LUM-SDF once daily (QD) for 1 day at 400 mg.

    Arm title
    		 Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day
    Arm description
    		 Participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumefantrine Solid Dispersion Formulation
    Investigational medicinal product code
    Other name
    LUM-SDF / LUM
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with KAF156 oncedaily (QD) for 1 day at 960 mg.

    Investigational medicinal product name
    KAF156
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with LUM-SDF once daily (QD) for 1 day at 800 mg.

    Arm title
    		 Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days
    Arm description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumefantrine Solid Dispersion Formulation
    Investigational medicinal product code
    Other name
    LUM-SDF / LUM
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with KAF156 oncedaily (QD) for 2 days at 960 mg.

    Investigational medicinal product name
    KAF156
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with LUM-SDF once daily (QD) for 2 days at 400 mg.

    Arm title
    		 Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days
    Arm description
    		 Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    KAF156
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with LUM-SDF once daily (QD) for 3 days at 200 mg.

    Investigational medicinal product name
    Lumefantrine Solid Dispersion Formulation
    Investigational medicinal product code
    Other name
    LUM-SDF / LUM
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with KAF156 oncedaily (QD) for 3 days at 480 mg.

    Arm title
    		 Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days
    Arm description
    		 Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumefantrine Solid Dispersion Formulation
    Investigational medicinal product code
    Other name
    LUM-SDF / LUM
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with KAF156 oncedaily (QD) for 3 days at 480 mg.

    Investigational medicinal product name
    KAF156
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with LUM-SDF once daily (QD) for 3 days at 400 mg.

    Arm title
    		 Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days
    Arm description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    KAF156
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with LUM-SDF once daily (QD) for 3 days at 400 mg.

    Investigational medicinal product name
    Lumefantrine Solid Dispersion Formulation
    Investigational medicinal product code
    Other name
    LUM-SDF / LUM
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with KAF156 oncedaily (QD) for 3 days at 960 mg.

    Arm title
    		 Part A - Cohort 7: Coartem
    Arm description
    		 Participants received Coartem twice daily via oral administration for 3 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Coartem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered twice daily for 3 days as active comparator

    Arm title
    		 Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day
    Arm description
    		 Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumefantrine Solid Dispersion Formulation
    Investigational medicinal product code
    Other name
    LUM-SDF / LUM
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with KAF156 oncedaily (QD) for 1 day at 960 mg.

    Investigational medicinal product name
    KAF156
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with LUM-SDF once daily (QD) for 1 day at 400 mg.

    Arm title
    		 Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days
    Arm description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumefantrine Solid Dispersion Formulation
    Investigational medicinal product code
    Other name
    LUM-SDF / LUM
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with KAF156 oncedaily (QD) for 2 days at 960 mg.

    Investigational medicinal product name
    KAF156
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with LUM-SDF once daily (QD) for 2 days at 400 mg.

    Arm title
    		 Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days
    Arm description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lumefantrine Solid Dispersion Formulation
    Investigational medicinal product code
    Other name
    LUM-SDF / LUM
    Pharmaceutical forms
    Oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with KAF156 oncedaily (QD) for 3 days at 960 mg.

    Investigational medicinal product name
    KAF156
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in combination with LUM-SDF once daily (QD) for 3 days at 400 mg.

    Arm title
    		 Part B - Cohort 4: Coartem
    Arm description
    		 Participants received Coartem twice daily via oral administration for 3 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Coartem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered twice daily for 3 days as active comparator

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: It is consistent
    Number of subjects in period 1
    		PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 day Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part A - Cohort 7: Coartem Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 4: Coartem
    Started
    12
    51
    51
    51
    54
    51
    52
    27
    53
    53
    45
    24
    Full Analysis Set (FAS)
    12
    51
    51
    51
    54
    51
    52
    27
    52
    53
    45
    24
    Pharmacokinetics (PK) Analysis Set
    12
    47 [2]
    51
    46 [3]
    48 [4]
    46 [5]
    45 [6]
    24 [7]
    48 [8]
    46 [9]
    41 [10]
    24
    Per-Protocol Set (PPS)
    12
    50
    48
    48 [11]
    47 [12]
    44 [13]
    43 [14]
    25 [15]
    48 [16]
    46 [17]
    40 [18]
    22 [19]
    Completed
    12
    50
    48
    50
    53
    49
    50
    26
    52
    53
    43
    23
    Not completed
    0
    1
    3
    1
    1
    2
    2
    1
    1
    0
    2
    1
         Patient/Guardian Decision
    -
    1
    2
    1
    1
    1
    -
    -
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    1
    -
    -
    1
    2
    1
    -
    -
    1
    1
         Missing
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    Notes
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [15] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [16] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [17] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [18] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent
    [19] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Numbers are consistent

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 day
    Reporting group description
    		 Participants received a single oral dose of KAF156 200 mg and LUM-SDF 960 mg

    Reporting group title
    Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day
    Reporting group description
    		 Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg

    Reporting group title
    Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day
    Reporting group description
    		 Participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg

    Reporting group title
    Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days
    Reporting group description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days

    Reporting group title
    Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days
    Reporting group description
    		 Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days

    Reporting group title
    Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days
    Reporting group description
    		 Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days

    Reporting group title
    Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days
    Reporting group description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days

    Reporting group title
    Part A - Cohort 7: Coartem
    Reporting group description
    		 Participants received Coartem twice daily via oral administration for 3 days

    Reporting group title
    Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day
    Reporting group description
    		 Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg

    Reporting group title
    Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days
    Reporting group description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days

    Reporting group title
    Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days
    Reporting group description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days

    Reporting group title
    Part B - Cohort 4: Coartem
    Reporting group description
    		 Participants received Coartem twice daily via oral administration for 3 days

    Reporting group values
    		 PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 day Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part A - Cohort 7: Coartem Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 4: Coartem Total
    Number of subjects
    		 12 51 51 51 54 51 52 27 53 53 45 24 524
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 2 1 0 0 0 0 1 53 53 45 24 179
        Adolescents (12-17 years)
    		 10 25 25 29 31 33 31 13 0 0 0 0 197
        Adults (18-64 years)
    		 2 24 25 22 23 18 21 13 0 0 0 0 148
        From 65-84 years
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 17.8 ± 10.25 22.3 ± 13.53 21.3 ± 10.69 21.1 ± 11.09 23.3 ± 14.68 20.3 ± 11.90 20.0 ± 9.49 20.9 ± 12.28 6.6 ± 2.86 6.2 ± 2.90 6.9 ± 2.60 5.9 ± 2.21 -
    Sex: Female, Male
    Units: Participants
        Female
    		 6 26 24 21 26 25 20 13 31 29 20 15 256
        Male
    		 6 25 27 30 28 26 32 14 22 24 25 9 268
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Asian
    		 0 7 7 7 9 7 7 4 1 1 0 0 50
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Black or African American
    		 12 44 44 43 45 44 45 23 52 52 45 24 473
        White
    		 0 0 0 1 0 0 0 0 0 0 0 0 1
        More than one race
    		 0 0 0 0 0 0 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0 0 0 0 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 day
    Reporting group description
    		 Participants received a single oral dose of KAF156 200 mg and LUM-SDF 960 mg

    Reporting group title
    Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day
    Reporting group description
    		 Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg

    Reporting group title
    Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day
    Reporting group description
    		 Participants received a single oral dose of KAF156 800 mg and LUM-SDF 960 mg

    Reporting group title
    Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days
    Reporting group description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days

    Reporting group title
    Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days
    Reporting group description
    		 Participants received KAF156 200 mg and LUM-SDF 480 mg once daily via oral administration for 3 days

    Reporting group title
    Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days
    Reporting group description
    		 Participants received KAF156 400 mg and LUM-SDF 480 mg once daily via oral administration for 3 days

    Reporting group title
    Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days
    Reporting group description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days

    Reporting group title
    Part A - Cohort 7: Coartem
    Reporting group description
    		 Participants received Coartem twice daily via oral administration for 3 days

    Reporting group title
    Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day
    Reporting group description
    		 Participants received a single oral dose of KAF156 400 mg and LUM-SDF 960 mg

    Reporting group title
    Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days
    Reporting group description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 2 days

    Reporting group title
    Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days
    Reporting group description
    		 Participants received KAF156 400 mg and LUM-SDF 960 mg once daily via oral administration for 3 days

    Reporting group title
    Part B - Cohort 4: Coartem
    Reporting group description
    		 Participants received Coartem twice daily via oral administration for 3 days

    Primary: Part A and Part B: Number of participants with Polymerase Chain Reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) at Day 29

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    End point title
    		 Part A and Part B: Number of participants with Polymerase Chain Reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) at Day 29 [1] [2]
    End point description
    PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at Day 29 (i.e., 28 days post first dose) based on the short half-life of the study drugs. Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR at Day 29 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 29 irrespective of axillary temperature unless the presence of parasitaemia after 7 days was due to reinfection based on PCR. A presence of parasitaemia after 7 days of treatment initiation was considered as a reinfection only if the parasitaemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    28 days post first dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part A - Cohort 7: Coartem Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 4: Coartem
    Number of subjects analysed
    50
    48
    48
    47
    44
    43
    25
    48
    46
    40
    22
    Units: Participants
    46
    45
    47
    47
    44
    42
    25
    37
    42
    38
    21
    No statistical analyses for this end point

    Primary: PK Run-in: Area under the blood concentration-time curve over the last 24 hours after treatment dose (AUC0-24h) of KAF156

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    End point title
    		 PK Run-in: Area under the blood concentration-time curve over the last 24 hours after treatment dose (AUC0-24h) of KAF156 [3] [4]
    End point description
    Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUC0-24h was determined using non-compartmental methods. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    0, 1, 3, 6, 12, 18 and 24 hours post-dose
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned for this endpoint
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 day
    Number of subjects analysed
    11
    Units: hours*μg/mL
        geometric mean (geometric coefficient of variation)
    5.35 ± 34.8
    No statistical analyses for this end point

    Secondary: Part A and Part B: Number of participants with Polymerase Chain Reaction (PCR)-uncorrected adequate clinical and parasitological response (ACPR)

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    End point title
    		 Part A and Part B: Number of participants with Polymerase Chain Reaction (PCR)-uncorrected adequate clinical and parasitological response (ACPR) [5]
    End point description
    PCR-uncorrected ACPR defined as the absence of parasitaemia was evaluated at days 15, 29 and 43 (i.e., 14, 28 and 42 days post first dose). A participant was considered as PCR-uncorrected ACPR at Days 15, 29 or 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Days 15, 29 or 43 irrespective of axillary temperature.
    End point type
    Secondary
    End point timeframe
    14, 28 and 42 days post first dose
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part A - Cohort 7: Coartem Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 4: Coartem
    Number of subjects analysed
    51
    51
    51
    54
    51
    52
    27
    52
    53
    45
    24
    Units: Participants
        Day 14 post-dose
    49
    47
    51
    53
    50
    51
    27
    51
    52
    43
    24
        Day 28 post-dose
    46
    40
    48
    51
    45
    47
    26
    34
    41
    36
    15
        Day 42 post-dose
    42
    36
    45
    45
    41
    45
    19
    29
    33
    31
    11
    No statistical analyses for this end point

    Secondary: Part A and Part B: Number of participants with Polymerase Chain Reaction (PCR)-corrected adequate clinical and parasitological response (ACPR)

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    End point title
    		 Part A and Part B: Number of participants with Polymerase Chain Reaction (PCR)-corrected adequate clinical and parasitological response (ACPR) [6]
    End point description
    PCR-corrected ACPR defined as the absence of parasitaemia was evaluated at days 15 and 43 (i.e., 14 and 42 days post first dose). Microscopic species identification was confirmed and determined by PCR genotyping methods to establish malaria recrudescence/reinfection. A participant was considered as PCR-corrected ACPR at Day 15 or Day 43 if the participant did not meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure and was absence of parasitaemia on Day 15 or Day 43 irrespective of axillary temperature unless the presence of parasitaemia after 7 days was due to reinfection based on PCR. A presence of parasitaemia after 7 days of treatment initiation was considered as a reinfection only if the parasitaemia was clear before Day 8 and none of the parasite strain(s) detected on Day 8 or later matched with the parasite strain at baseline based on PCR.
    End point type
    Secondary
    End point timeframe
    14 and 42 days post first dose
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part A - Cohort 7: Coartem Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 4: Coartem
    Number of subjects analysed
    50
    48
    48
    47
    44
    43
    25
    48
    46
    40
    22
    Units: Participants
        Day 14 post-dose
    48
    46
    48
    47
    44
    43
    25
    47
    45
    40
    22
        Day 42 post-dose
    45
    44
    46
    46
    43
    41
    24
    36
    37
    37
    20
    No statistical analyses for this end point

    Secondary: Part A and Part B: Number of participants with recrudescence events

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    End point title
    		 Part A and Part B: Number of participants with recrudescence events [7]
    End point description
    Recrudescence is defined as appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at baseline. Recrudescence must be confirmed by PCR analysis.
    End point type
    Secondary
    End point timeframe
    42 days post first dose
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part A - Cohort 7: Coartem Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 4: Coartem
    Number of subjects analysed
    51
    51
    51
    54
    51
    52
    27
    52
    53
    45
    24
    Units: Participants
    4
    3
    1
    1
    0
    2
    0
    12
    7
    3
    2
    No statistical analyses for this end point

    Secondary: Part A and Part B: Number of participants with reinfection events

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    End point title
    		 Part A and Part B: Number of participants with reinfection events [8]
    End point description
    Reinfection is defined as appearance of asexual parasites after clearance of initial infection with a genotype different from those parasites present at baseline. Reinfection must be confirmed by PCR analysis.
    End point type
    Secondary
    End point timeframe
    42 days post first dose
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part A - Cohort 7: Coartem Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 4: Coartem
    Number of subjects analysed
    51
    51
    51
    54
    51
    52
    27
    52
    53
    45
    24
    Units: Participants
    3
    7
    4
    7
    8
    2
    8
    11
    10
    9
    10
    No statistical analyses for this end point

    Secondary: Part A and Part B: Fever clearance time (FCT)

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    End point title
    		 Part A and Part B: Fever clearance time (FCT) [9]
    End point description
    Fever Clearance Time (FCT) is defined as the time from the first dose until the first time the axillary body temperature decreased below and remained below 37.5°C axillary or 38.0°C oral/tympanic/rectal for at least a further 24 hours. In case a participant received rescue medication before (fever) clearance, the time to event was censored at the first use of rescue medication.
    End point type
    Secondary
    End point timeframe
    42 days post first dose
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part A - Cohort 7: Coartem Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 4: Coartem
    Number of subjects analysed
    16
    7
    8
    15
    13
    9
    5
    9
    11
    10
    5
    Units: Hours
        arithmetic mean (standard error)
    18.7 ± 3.09
    22.5 ± 6.09
    20.3 ± 4.92
    16.6 ± 3.48
    17.5 ± 2.65
    19.2 ± 2.92
    26.3 ± 7.67
    23.5 ± 10.26
    17.3 ± 7.4
    13.8 ± 3.68
    22.9 ± 12.78
    No statistical analyses for this end point

    Secondary: PK Run-in, Part A and Part B: Parasite Clearance time (PCT)

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    End point title
    		 PK Run-in, Part A and Part B: Parasite Clearance time (PCT)
    End point description
    Parasite Clearance Time (PCT) is defined as the time from the first dose until the first total and continued disappearance of asexual parasite forms which remained at least a further 48 hours. In case a participant received rescue medication before (parasite) clearance, the time to event was censored at the first use of rescue medication.
    End point type
    Secondary
    End point timeframe
    42 days post first
    End point values
    		 PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 day Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part A - Cohort 7: Coartem Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 4: Coartem
    Number of subjects analysed
    12
    51
    51
    51
    54
    51
    52
    27
    52
    53
    45
    24
    Units: Hours
        arithmetic mean (standard error)
    49.9 ± 4.35
    48.4 ± 3.5
    46.6 ± 3.93
    39.9 ± 2.46
    51.4 ± 3.97
    49.7 ± 3.72
    48.1 ± 4.24
    50.0 ± 12.82
    42.6 ± 2.62
    47.0 ± 2.79
    41.9 ± 2.58
    35.6 ± 2.82
    No statistical analyses for this end point

    Secondary: PK Run-in, Part A and Part B: Number of participants with parasitaemia

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    End point title
    		 PK Run-in, Part A and Part B: Number of participants with parasitaemia
    End point description
    Parasitaemia is the quantitative content of parasites in the blood determined by microscopy examination validated methods. Only Plasmodium Falciparum asexual form is used for parasitaemia assessments. 12 h post last dose n= (12, 50, 50, 49, 52, 50, 51, 27, 51, 53, 45, 24) 24 h post last dose n= (12, 49, 51, 51, 54, 50, 50, 27, 51, 52, 44, 24) 48 h post last dose n= (12, 50, 51, 51, 53, 49, 52, 26, 51, 52, 44, 24)
    End point type
    Secondary
    End point timeframe
    14, 28 and 42 days post last dose
    End point values
    		 PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 day Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part A - Cohort 7: Coartem Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 4: Coartem
    Number of subjects analysed
    12
    51
    51
    51
    54
    51
    52
    27
    52
    53
    45
    24
    Units: Participants
        12 h post last dose
    12
    46
    46
    44
    52
    49
    49
    22
    48
    48
    42
    22
        24 h post last dose
    11
    39
    41
    38
    46
    42
    34
    14
    41
    42
    36
    17
        48 h post last dose
    3
    13
    9
    8
    12
    10
    11
    4
    4
    10
    5
    1
    No statistical analyses for this end point

    Secondary: Part A and Part B: Area under the blood concentration-time curve over the last 24 hours after last treatment dose (AUC0-24h) of KAF156

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    End point title
    		 Part A and Part B: Area under the blood concentration-time curve over the last 24 hours after last treatment dose (AUC0-24h) of KAF156 [10]
    End point description
    Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. AUC0-24h was determined using non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    3, 6, 18 and 24 hours post last dose
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days
    Number of subjects analysed
    38
    44
    41
    43
    36
    41
    48
    0 [11]
    0 [12]
    Units: hours*μg/mL
        geometric mean (geometric coefficient of variation)
    9.84 ± 41.5
    21.7 ± 41.7
    9.95 ± 131.9
    5.91 ± 29.2
    11 ± 79.3
    10.9 ± 57.4
    11 ± 47.7
    ±
    ±
    Notes
    [11] - Not performed as per the study design for Part B dosing regimens of 2 and 3 days.
    [12] - Not performed as per the study design for Part B dosing regimens of 2 and 3 days.
    No statistical analyses for this end point

    Secondary: Part A and Part B: Maximum Peak Observed Concentration (Cmax) of KAF156

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    End point title
    		 Part A and Part B: Maximum Peak Observed Concentration (Cmax) of KAF156 [13]
    End point description
    Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Cmax was determined using non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    3, 6, 18, 24, 27, 30, 48, 51, 54, 68, 72 and 168 hours post last dose
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days Part B - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part B - Cohort 2: KAF 400 mg and LUM 960 mg QD for 2 days Part B - Cohort 3: KAF 400 mg and LUM 960 mg QD for 3 days
    Number of subjects analysed
    39
    44
    40
    43
    36
    41
    48
    46
    41
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    653 ± 43.9
    1470 ± 46.5
    1060 ± 83.9
    665 ± 30.3
    1470 ± 30.9
    1320 ± 32.7
    714 ± 49.4
    1060 ± 48.4
    1380 ± 29.7
    No statistical analyses for this end point

    Secondary: PK Run-in and Part A: Elimination half-life (T½) of KAF156

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    End point title
    		 PK Run-in and Part A: Elimination half-life (T½) of KAF156 [14]
    End point description
    Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. T½ was determined using non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    0, 1, 3, 6, 12, 18, 24, 27, 30, 36, 48, 72, 96 and 168 hours post last dose
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 day Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day Part A - Cohort 3: KAF 400 mg and LUM 960 mg QD for 2 days Part A - Cohort 4: KAF 200 mg and LUM 480 mg QD for 3 days Part A - Cohort 5: KAF 400 mg and LUM 480 mg QD for 3 days Part A - Cohort 6: KAF 400 mg and LUM 960 mg QD for 3 days
    Number of subjects analysed
    11
    4
    6
    4
    2
    9
    2
    Units: Hours
        arithmetic mean (standard deviation)
    25.0 ± 8.81
    25.4 ± 5.32
    29.9 ± 9.95
    31.0 ± 3.86
    35.8 ± 19.4
    28.4 ± 3.49
    26.6 ± 4.15
    No statistical analyses for this end point

    Secondary: PK Run-in and Part A: Time to Reach Maximum Blood Concentrations (Tmax) of KAF156

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    End point title
    		 PK Run-in and Part A: Time to Reach Maximum Blood Concentrations (Tmax) of KAF156 [15]
    End point description
    Pharmacokinetic (PK) parameters were calculated based on KAF156 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method. Tmax was determined using non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    0, 1, 3, 6, 12, 18, 24, 30, 48, 96 and 168 hours post last dose
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analysis was planned for this endpoint
    End point values
    		 PK Run-in Cohort: KAF 200 mg and LUM 960 mg QD for 1 day Part A - Cohort 1: KAF 400 mg and LUM 960 mg QD for 1 day Part A - Cohort 2: KAF 800 mg and LUM 960 mg QD for 1 day
    Number of subjects analysed
    12
    5
    6
    Units: Hours
        arithmetic mean (standard deviation)
    4.23 ± 1.55
    39.8 ± 77.3
    5.99 ± 3.11
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from first dose of study treatment until end of study treatment plus 40, 41 or 42 days post treatment depending on whether the participant received treatment during 1, 2 or 3 consecutive days respectively.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    KAF200mg/@LUM960mg-1D@(PK Run-in)
    Reporting group description
    		 KAF200mg/@LUM960mg-1D@(PK Run-in)

    Reporting group title
    KAF400mg/@LUM960mg-1D
    Reporting group description
    		 KAF400mg/@LUM960mg-1D

    Reporting group title
    KAF800mg/@LUM960mg-1D
    Reporting group description
    		 KAF800mg/@LUM960mg-1D

    Reporting group title
    KAF400mg/@LUM960mg-2D
    Reporting group description
    		 KAF400mg/@LUM960mg-2D

    Reporting group title
    KAF200mg/@LUM480mg-3D
    Reporting group description
    		 KAF200mg/@LUM480mg-3D

    Reporting group title
    KAF400mg/@LUM480mg-3D
    Reporting group description
    		 KAF400mg/@LUM480mg-3D

    Reporting group title
    KAF400mg/@LUM960mg-3D
    Reporting group description
    		 KAF400mg/@LUM960mg-3D

    Reporting group title
    Coartem
    Reporting group description
    		 Coartem

    Serious adverse events
    		 KAF200mg/@LUM960mg-1D@(PK Run-in) KAF400mg/@LUM960mg-1D KAF800mg/@LUM960mg-1D KAF400mg/@LUM960mg-2D KAF200mg/@LUM480mg-3D KAF400mg/@LUM480mg-3D KAF400mg/@LUM960mg-3D Coartem
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    7 / 103 (6.80%)
    1 / 51 (1.96%)
    5 / 104 (4.81%)
    2 / 54 (3.70%)
    1 / 51 (1.96%)
    2 / 97 (2.06%)
    3 / 51 (5.88%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 103 (0.00%)
    0 / 51 (0.00%)
    0 / 104 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 103 (0.00%)
    0 / 51 (0.00%)
    0 / 104 (0.00%)
    1 / 54 (1.85%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 103 (2.91%)
    0 / 51 (0.00%)
    2 / 104 (1.92%)
    1 / 54 (1.85%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    3 / 51 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    2 / 2
    0 / 1
    0 / 0
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 103 (1.94%)
    0 / 51 (0.00%)
    2 / 104 (1.92%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    1 / 97 (1.03%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 103 (0.97%)
    0 / 51 (0.00%)
    0 / 104 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 103 (0.00%)
    0 / 51 (0.00%)
    1 / 104 (0.96%)
    0 / 54 (0.00%)
    1 / 51 (1.96%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis acute
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 103 (0.97%)
    0 / 51 (0.00%)
    0 / 104 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 103 (0.97%)
    0 / 51 (0.00%)
    0 / 104 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Petechiae
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 103 (0.00%)
    0 / 51 (0.00%)
    0 / 104 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    1 / 97 (1.03%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 103 (0.00%)
    0 / 51 (0.00%)
    1 / 104 (0.96%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasmodium falciparum infection
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 103 (0.00%)
    1 / 51 (1.96%)
    0 / 104 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 103 (0.00%)
    0 / 51 (0.00%)
    0 / 104 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    1 / 97 (1.03%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 103 (0.00%)
    0 / 51 (0.00%)
    1 / 104 (0.96%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 KAF200mg/@LUM960mg-1D@(PK Run-in) KAF400mg/@LUM960mg-1D KAF800mg/@LUM960mg-1D KAF400mg/@LUM960mg-2D KAF200mg/@LUM480mg-3D KAF400mg/@LUM480mg-3D KAF400mg/@LUM960mg-3D Coartem
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 12 (58.33%)
    69 / 103 (66.99%)
    37 / 51 (72.55%)
    68 / 104 (65.38%)
    30 / 54 (55.56%)
    32 / 51 (62.75%)
    59 / 97 (60.82%)
    30 / 51 (58.82%)
    Investigations
    Blood phosphorus increased
         subjects affected / exposed
    4 / 12 (33.33%)
    0 / 103 (0.00%)
    0 / 51 (0.00%)
    0 / 104 (0.00%)
    1 / 54 (1.85%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    4
    0
    0
    0
    1
    0
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 12 (8.33%)
    5 / 103 (4.85%)
    5 / 51 (9.80%)
    6 / 104 (5.77%)
    9 / 54 (16.67%)
    9 / 51 (17.65%)
    9 / 97 (9.28%)
    3 / 51 (5.88%)
         occurrences all number
    1
    6
    5
    6
    9
    9
    9
    3
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    4 / 103 (3.88%)
    4 / 51 (7.84%)
    1 / 104 (0.96%)
    1 / 54 (1.85%)
    0 / 51 (0.00%)
    3 / 97 (3.09%)
    0 / 51 (0.00%)
         occurrences all number
    0
    4
    4
    1
    1
    0
    4
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 12 (0.00%)
    16 / 103 (15.53%)
    10 / 51 (19.61%)
    13 / 104 (12.50%)
    15 / 54 (27.78%)
    7 / 51 (13.73%)
    14 / 97 (14.43%)
    7 / 51 (13.73%)
         occurrences all number
    0
    17
    13
    16
    19
    8
    19
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    5 / 103 (4.85%)
    0 / 51 (0.00%)
    3 / 104 (2.88%)
    1 / 54 (1.85%)
    1 / 51 (1.96%)
    5 / 97 (5.15%)
    1 / 51 (1.96%)
         occurrences all number
    0
    6
    0
    4
    1
    1
    5
    1
    Eosinophilia
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 103 (0.00%)
    2 / 51 (3.92%)
    1 / 104 (0.96%)
    3 / 54 (5.56%)
    2 / 51 (3.92%)
    3 / 97 (3.09%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    2
    1
    3
    2
    4
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 103 (0.97%)
    3 / 51 (5.88%)
    1 / 104 (0.96%)
    1 / 54 (1.85%)
    5 / 51 (9.80%)
    0 / 97 (0.00%)
    2 / 51 (3.92%)
         occurrences all number
    0
    1
    3
    1
    1
    5
    0
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 12 (0.00%)
    20 / 103 (19.42%)
    5 / 51 (9.80%)
    18 / 104 (17.31%)
    4 / 54 (7.41%)
    6 / 51 (11.76%)
    9 / 97 (9.28%)
    13 / 51 (25.49%)
         occurrences all number
    0
    22
    5
    18
    5
    6
    9
    13
    Treatment failure
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 103 (2.91%)
    3 / 51 (5.88%)
    0 / 104 (0.00%)
    3 / 54 (5.56%)
    2 / 51 (3.92%)
    1 / 97 (1.03%)
    2 / 51 (3.92%)
         occurrences all number
    0
    3
    3
    0
    3
    2
    1
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 103 (2.91%)
    3 / 51 (5.88%)
    5 / 104 (4.81%)
    2 / 54 (3.70%)
    7 / 51 (13.73%)
    4 / 97 (4.12%)
    0 / 51 (0.00%)
         occurrences all number
    0
    3
    3
    6
    2
    9
    4
    0
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 103 (0.97%)
    4 / 51 (7.84%)
    3 / 104 (2.88%)
    1 / 54 (1.85%)
    2 / 51 (3.92%)
    3 / 97 (3.09%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    4
    3
    1
    2
    4
    0
    Vomiting
         subjects affected / exposed
    0 / 12 (0.00%)
    8 / 103 (7.77%)
    8 / 51 (15.69%)
    9 / 104 (8.65%)
    2 / 54 (3.70%)
    3 / 51 (5.88%)
    8 / 97 (8.25%)
    2 / 51 (3.92%)
         occurrences all number
    0
    8
    8
    9
    2
    3
    8
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 12 (0.00%)
    7 / 103 (6.80%)
    3 / 51 (5.88%)
    10 / 104 (9.62%)
    3 / 54 (5.56%)
    5 / 51 (9.80%)
    6 / 97 (6.19%)
    4 / 51 (7.84%)
         occurrences all number
    0
    7
    4
    11
    3
    5
    6
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 103 (1.94%)
    0 / 51 (0.00%)
    3 / 104 (2.88%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    2 / 97 (2.06%)
    0 / 51 (0.00%)
         occurrences all number
    1
    2
    0
    3
    0
    0
    2
    0
    Infection parasitic
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 103 (0.00%)
    0 / 51 (0.00%)
    0 / 104 (0.00%)
    1 / 54 (1.85%)
    0 / 51 (0.00%)
    0 / 97 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    1
    Malaria
         subjects affected / exposed
    0 / 12 (0.00%)
    28 / 103 (27.18%)
    8 / 51 (15.69%)
    25 / 104 (24.04%)
    4 / 54 (7.41%)
    6 / 51 (11.76%)
    16 / 97 (16.49%)
    18 / 51 (35.29%)
         occurrences all number
    0
    29
    8
    25
    4
    6
    17
    18
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    15 / 103 (14.56%)
    6 / 51 (11.76%)
    12 / 104 (11.54%)
    5 / 54 (9.26%)
    3 / 51 (5.88%)
    12 / 97 (12.37%)
    5 / 51 (9.80%)
         occurrences all number
    0
    15
    6
    14
    5
    3
    12
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Feb 2017
    PK Run-in Part was included in the amended study protocol. This first part of the study will explore the PK and safety of KAF156 given in combination with LUM-SDF to understand the impact of LUM-SDF on KAF156 exposure as victim drug.
    13 Apr 2018
    Protocol was amended to correct several errors/inconsistencies, and provide clarifications.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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