Clinical Trial Results:
An open-label, mass balance study to investigate the absorption, distribution, metabolism and excretion of [14C]-etripamil nasal spray after a single dose to healthy male subjects
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Summary
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EudraCT number |
2019-004979-39 |
Trial protocol |
NL |
Global end of trial date |
09 Nov 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Jun 2022
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First version publication date |
24 Jun 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MSP-2017-1220
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Milestone Pharmaceuticals Inc.
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Sponsor organisation address |
1111 Dr.-Frederik-Philips Blvd, Ste. 420, Montreal, Canada, H4M 2X6
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Public contact |
Guy Rousseau, Milestone Pharmaceuticals Inc. , +1 5143360444228, grousseau@milestonepharma.com
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Scientific contact |
Guy Rousseau, Milestone Pharmaceuticals Inc. , +1 5143360444228, grousseau@milestonepharma.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-002303-PIP01-17 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 Jun 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Nov 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Nov 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine the ratio of parent drug to metabolites in the circulation.
Profiling of [14C]-etripamil metabolites in blood, urine and feces.
To determine the mass balance of drug-related materials following intranasal administration.
To determine the primary route of excretion of drug-related materials.
To determine the total radioactivity versus time profile in plasma and whole blood.
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Protection of trial subjects |
To safeguard the study subjects and the site staff, testing for COVID-19 was performed. A SARS-CoV-2 PCR was performed on nasal and/or throat swabs. The testing was performed one day prior to the scheduled study admittance day of the treatment period (Day -2). An extra residence day and night in the clinic was added for the treatment period where subjects came in one day prior to the scheduled study admittance day.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Oct 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 7
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Worldwide total number of subjects |
7
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EEA total number of subjects |
7
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
7
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited in Netherlands and signed inform consent form between 02-Oct-2020 and 16-Oct-2020. | ||||||
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Pre-assignment
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Screening details |
The subject population included healthy male subjects who satisfied all entry criteria (Inclusion and exclusion criteria met). | ||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
This study was not blinded
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Arms
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Arm title
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Overall study | ||||||
Arm description |
Only 1 arm for this study | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Etripamil Nasal Spray
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Investigational medicinal product code |
MSP-2017
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Other name |
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Pharmaceutical forms |
Nasal spray, solution in single-dose container
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Routes of administration |
Intranasal use
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Dosage and administration details |
A single dose of 70 mg etripamil nasal spray containing 96.9 µCi of radioactivity was administered to the subjects. The formulation of the radiolabeled etripamil nasal spray consisted of etripamil, [14C]-etripamil, water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to adjust pH to 4.4.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Pharmacokinetics set
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
This analysis set comprised all subjects who received the study drug, had no major protocol deviation associated with inclusion and exclusion criteria, and did not violate the protocol in a way that could affect the evaluation of the primary endpoints, i.e., without major protocol violations or deviations. The Pharmacokinetics set was employed in the analysis of PK and radioactivity endpoints.
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Subject analysis set title |
Safety set
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
This analysis set included all subjects who received the study drug. The Safety set was employed in the analysis of tolerability and safety variables
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Subject analysis set title |
Metabolite profiling set
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Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
This analysis set comprised all subjects who received the study drug, had no major protocol deviation associated with inclusion and exclusion criteria, and did not violate the protocol in a way that could affect the evaluation of the primary endpoints, i.e., without major protocol violations or deviations.
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End points reporting groups
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Reporting group title |
Overall study
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Reporting group description |
Only 1 arm for this study | ||
Subject analysis set title |
Pharmacokinetics set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
This analysis set comprised all subjects who received the study drug, had no major protocol deviation associated with inclusion and exclusion criteria, and did not violate the protocol in a way that could affect the evaluation of the primary endpoints, i.e., without major protocol violations or deviations. The Pharmacokinetics set was employed in the analysis of PK and radioactivity endpoints.
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Subject analysis set title |
Safety set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
This analysis set included all subjects who received the study drug. The Safety set was employed in the analysis of tolerability and safety variables
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Subject analysis set title |
Metabolite profiling set
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
This analysis set comprised all subjects who received the study drug, had no major protocol deviation associated with inclusion and exclusion criteria, and did not violate the protocol in a way that could affect the evaluation of the primary endpoints, i.e., without major protocol violations or deviations.
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End point title |
Whole blood - Area under the total radioactivity-time curve from time zero to the last measurable concentration (AUC0-t) [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| 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: Study was not designed to be powered for statistical analysis |
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| No statistical analyses for this end point | |||||||||
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End point title |
Whole blood - Area under the total radioactivity-time curve from time zero to infinity (AUC0-inf) [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| Notes [2] - 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: Study was not designed to be powered for statistical analysis |
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| Notes [3] - This parameter was not estimated as the AUC0-t / AUC0-inf ratio was less than 0.80. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma - Maximum observed total radioactivity (Cmax) [4] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| Notes [4] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma - Time from time zero to peak total radioactivity (tmax) [5] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| Notes [5] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma - Area under the total radioactivity-time curve from time zero to the last measurable concentration of total radioactivity (AUC0-t) [6] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| Notes [6] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma - Area under the total radioactivity-time curve from time zero to infinity (AUC0-inf) [7] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| Notes [7] - 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: Study was not designed to be powered for statistical analysis. |
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| Notes [8] - The AUC0-inf could not be determined, as the AUC0-t / AUC0-inf ratio was l |
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma - Total radioactivity half-life (t1/2) [9] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| Notes [9] - 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: Study was not designed to be powered for statistical analysis. |
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| Notes [10] - The t1/2 could not be determined, as the AUC0-t / AUC0-inf ratio was less than 0.8. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma - Apparent total radioactivity clearance (CL/F) [11] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| Notes [11] - 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: Study was not designed to be powered for statistical analysis. |
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| Notes [12] - The CL/F could not be determined, as the AUC0-t / AUC0-inf ratio was less than 0.8 |
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma - volume of distribution (Vz/F) [13] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| Notes [13] - 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: Study was not designed to be powered for statistical analysis. |
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| Notes [14] - The Vz/F could not be determined, as the AUC0-t / AUC0-inf ratio was less than 0.8. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Urine - Total radioactivity amount excreted in urine (Aeu) [15] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose and 0-120, 120-240, 240-360, 360-720, 720-1440 minutes post-dose, Day 2, Day 3, Day 4
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| Notes [15] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Urine - Total radioactivity excreted as a percentage of the radioactive dose. [16] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose and 0-120, 120-240, 240-360, 360-720, 720-1440 minutes post-dose, Day 2, Day 3, Day 4
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| Notes [16] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma - 14C]-metabolic profile and identification of metabolites [17] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
0.0833, 0.117, 0.167, 0.25, 0.417, 0.833, 1.5, 6 hours
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| Notes [17] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Urine - [14C]-metabolic profile and identification of metabolites [18] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
0-2, 2-4, 2-6, 6-12, 12-24, 24-48, 48-72
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| Notes [18] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Urine - Major radioactive peak/metabolite(s) in radiochromatogram(s) as a percentage of the radioactive dose [19] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
0-2, 2-4, 2-6, 6-12, 12-24, 24-48, 48-72
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| Notes [19] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Feces - Total radioactivity percentage dose excreted [20] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 1 (dosing), Day 2, Day 3, Day 4
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| Notes [20] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Feces - [14C]-metabolic profile and identification of metabolites [21] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 1 (dosing), Day 2, Day 3, Day 4
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| Notes [21] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Feces - Major radioactive peak/metabolite(s) in radiochromatogram(s) as a percentage of the radioactive dose. [22] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 1 (dosing), Day 2, Day 3, Day 4
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| Notes [22] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Whole blood - Maximum observed total radioactivity (Cmax) [23] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| Notes [23] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Whole blood - Time from time zero to peak total radioactivity (tmax) [24] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| Notes [24] - 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: Study was not designed to be powered for statistical analysis. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Safety and Tolerability - Number of SAE | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Continuous monitoring from signature of inform consent to end-of-study (EOS). Adverse events were followed until resolution, or to a maximum of 28 days after the EOS.
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| No statistical analyses for this end point | |||||||||
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End point title |
Maximum observed concentration (Cmax) - Etripamil plasma | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| No statistical analyses for this end point | |||||||||
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End point title |
Maximum observed concentration (Cmax) - MSP-2030 plasma | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| No statistical analyses for this end point | |||||||||
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End point title |
Time from time zero to peak concentration (tmax) - etripamil plasma | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
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| No statistical analyses for this end point | |||||||||
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|||||||||
End point title |
Time from time zero to peak concentration (tmax) - MSP-2030 plasma | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) - etripamil plasma | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) - MSP-2030 plasma | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Area under the concentration-time curve from time zero to infinity (AUC0-inf) - etripamil plasma | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Area under the concentration-time curve from time zero to infinity (AUC0-inf) - MSP-2030 plasma | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Terminal half-life (t1/2) - etripamil plasma | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Terminal half-life (t1/2) - MSP-2030 plasma | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Apparent clearance (CL/F) - etripamil plasma | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
volume of distribution (Vz/F) - etripamil plasma | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose, 0.5, 1.5, 3. 5, 7, 10, 15, 25, 50, 90, 240, 360, 720 min post-dose on Day 1, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Amount excreted unchanged in urine (Aeu) - Etripamil | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose and 0-120, 120-240, 240-360, 360-720, 720-1440 minutes post-dose, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Fraction of dose excreted in urine (etripamil only) (fe) | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose and 0-120, 120-240, 240-360, 360-720, 720-1440 minutes post-dose, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Renal clearance, calculated as Aeu,0-t/AUC0-t (CLr) | ||||||||
End point description |
|||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Pre-dose and 0-120, 120-240, 240-360, 360-720, 720-1440 minutes post-dose, Day 2, Day 3, Day 4
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
All AEs occurring after the consent form is signed and up to the end-of-study (EOS) are reported. Adverse events must be followed until resolution, or to a maximum of 28 days after the EOS.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
22.1
|
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|
Reporting groups
|
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Reporting group title |
Overall study
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Only 1 arm for this study | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
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 | |||
