Clinical Trials Register

Summary
EudraCT Number:	2017-002127-16
Sponsor's Protocol Code Number:	UCAB-CT-03
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-07-05
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Finland - Fimea

A.2

EudraCT number

2017-002127-16

A.3

Full title of the trial

A phase IIa study of GR3027 in patients with idiopathic hypersomnia (IH) involving an open-label part to assess safety, tolerability and pharmacokinetics (PK) of a single oral GR3027 dose in female patients and a randomized, double-blind, placebo-controlled crossover study to assess safety, tolerability, exposure and exploratory efficacy of multiple oral doses of GR3027 in male and female IH patients.

GR3027-valmisteen käyttöä idiopaattisen liikaunisuuden hoidossa koskeva IIa vaiheen tutkimus, jonka avoimessa osiossa arvioidaan suun kautta otettavan GR3027-kertaannoksen turvallisuutta, siedettävyyttä ja farmakokinetiikkaa naisilla ja jonka satunnaistetussa, kaksoissokkoutetussa, lumekontrolloidussa, vaihtovuoroisessa tutkimusosiossa arvioidaan useasti suun kautta otettaviin GR3027-annoksiin liittyvää turvallisuutta, siedettävyyttä ja altistusta sekä tehokkuutta koskevia tietoja naisilla ja miehillä

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study in patients with idiopathic hypersomnia involving two parts. Part A is an an open-label study to assess safety, tolerability and pharmacokinetics of a single oral GR3027 dose in female patients. Part B is a randomized, double-blind, placebo-controlled crossover study to assess safety, tolerability, exposure and exploratory efficacy of multiple oral doses of GR3027 in male and female IH patients.

GR3027-valmisteen käyttöä tutkitaan liikaunisuuden hoidossa, jonka avoimessa osiossa arvioidaan suun kautta otettavan GR3027-kertaannoksen turvallisuutta, siedettävyyttä ja farmakokinetiikkaa naisilla ja jonka kaksoissokkoutetussa, lumekontrolloidussa tutkimusosiossa arvioidaan useasti suun kautta otettaviin GR3027-annoksiin liittyvää turvallisuutta, siedettävyyttä ja altistusta sekä tehokkuutta koskevia tietoja naisilla ja miehillä

A.4.1

Sponsor's protocol code number

UCAB-CT-03

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Umecrine Cognition AB
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Umecrine Cognition AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Umecrine Cognition AB
B.5.2	Functional name of contact point	Chief Executive Officer
B.5.3	Address:
B.5.3.1	Street Address	Fogdevreten 2
B.5.3.2	Town/ city	Solna
B.5.3.3	Post code	SE-17165
B.5.3.4	Country	Sweden
B.5.4	Telephone number	46852484484
B.5.6	E-mail	magnus.doverskog@umecrine.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	GR3027
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not yet available
D.3.9.1	CAS number	2089238-18-4
D.3.9.2	Current sponsor code	GR3027
D.3.9.3	Other descriptive name	GR3027
D.3.9.4	EV Substance Code	SUB180296
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	GR3027
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Not yet available
D.3.9.1	CAS number	2089238-18-4
D.3.9.2	Current sponsor code	GR3027
D.3.9.3	Other descriptive name	GR3027
D.3.9.4	EV Substance Code	SUB180296
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Idiopathic hypersomnia (IH)

E.1.1.1

Medical condition in easily understood language

Idiopathic hypersomnia (IH)

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLT
E.1.2	Classification code	10028714
E.1.2	Term	Narcolepsy and hypersomnia
E.1.2	System Organ Class	100000004852

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part A: The primary objective is to assess the safety and tolerability of GR3027 after a single oral dose of GR3027 in female patients with IH.

Part B: The primary objective is to assess the safety and tolerability of GR3027 after multiple dose administration in patients with IH.

E.2.2

Secondary objectives of the trial

Part A: The secondary objective is to determine the single oral dose PK characteristics of GR3027 in female patients with IH.

Part B: The secondary objectives are to evaluate the exploratory efficacy of GR3027 after multiple dose administration in patients with IH and to assess the exposure of GR3027 at steady state in patients with IH.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Have signed and dated an informed consent prior to beginning protocol required procedures.
2. In part A, females age 18 to 55 years. In part B, males or females age 18 to 55 years.
3. Meets the International Classification of Sleep Disorders criteria 3rd edition (ICSD-3) for the diagnosis of IH. The diagnosis is either done during screening or if within the last twelve months (as long as medical records are available for verification).
4. ESS of 11 or greater (as assessed at the screening visit)
5. An apnea-hypopnea index (AHI) < 15 within the last 12 months.
6. Patients on current treatment for their hypersomnolence disorder may be enrolled after discontinuing the medication and a washout phase (at least 5 x half-lives of medication but not less than 14 days). The following exception from the 14 days washout is allowed: 5 days washout for modafinil treatment prior to baseline.
7. Fertile female patients, willing to use a hormonal or non-hormonal intrauterine device (IUD) or condom together with a medically accepted method of birth control (diaphragm, sponge, cervical cap) or sexual abstinence and agree to continue use of this method for the duration of the study and thereafter for one month after the last dosing of the IMP. Fertile female patients using hormonal IUD must have had the IUD for at least a month and should plan to keep it during the study.
8. Fertile male patients must be willing to use condom and contraceptive methods with a failure rate of < 1% to prevent pregnancy1 and drug exposure of a fertile female partner and refrain from donating sperm from the date of dosing until one month after dosing of the IMP.
9. Women who are surgically sterile or two years post-menopausal may be included without fulfilling the above criteria on birth control.
10. Men who are surgically sterile may be included without they/their partner fulfilling the above criteria on birth control.

E.4

Principal exclusion criteria

1. History of pathological EEG as judged by the Investigator.
2. Pathological ECG at screening as judged by the Investigator.
3. Inability to swallow the required number of study medication capsules or otherwise comply with study procedures.
4. Any concurrent illness which at the discretion of the Investigator would compromise patient safety and/or compromise the objectives outlined in the protocol. These could include but are not limited to cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological (other than narcolepsy/hypersomnia), psychiatric (incl. but not limited to depression, anxiety), pulmonary, and/or renal disease.
5. Women with significant menstrual cycle related hypersomnolence (including premenstrual dysphoric syndrome (PMDS)).
6. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to GR3027.
7. Current or recent (within one year) history of abuse of drugs of abuse including alcohol, anabolic steroids or as defined by the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders).
8. Positive screen for drugs of abuse at screening or at baseline prior to administration of the study treatment.
9. Female patients who are pregnant or nursing.
10. Abnormal renal or hepatic function as reflected by a serum creatinine > 2.0 mg/dL (177 micromol/L) or abnormal liver biochemical tests (AST or ALT > 2 x upper limit of normal) or serum bilirubin (more than 1.5 times upper limit of normal).
11. Evidence of active chronic viral infection including hepatitis B (serum hepatitis B surface antigen positive), hepatitis C (e.g. HCV RNA positive), and/or Human Immunodeficiency Virus (HIV positive).
12. Have an occupation that requires variable shift work or routine night shift.
13. Participation in any other clinical study that included drug treatment with the last administration within the past 30 days or five half-lives (whichever is longer) prior to administration of study treatment in this study. Patients consented and screened but not dosed in previous clinical studies are not excluded.
14. Use of hypnotics, stimulants, tranquilizers, antihistamines (except for non-sedating antihistamines), benzodiazepines or clonidine at the within 14 days prior to enrolment or during the study. Patients taking anticonvulsants for epilepsy are not eligible to participate even if they are willing to washout anticonvulsants for the study.
15. Concomitant drugs that are metabolised by either CYP3A4, CYP2C8 or CYP2C9 and where there is a risk for drug-drug interactions will be prohibited during the study, as judged by the Investigator.
16. Use of over the counter (OTC) products, prescription medications or off label medications for hypersomnolence disorders must be discontinued at least 5 x half-lives of the medication but not less than 14 days prior to baseline. The following exception from the 14 days washout is allowed: 5 days washout for modafinil treatment prior to baseline.
17. Regular or recent (i.e. within 14 days prior to enrolment) use of any prescribed or nonprescribed medications which, at the discretion of the Investigator, might compromise safe patient participation in the study and/or interpretation of the study results.
18. Unsuitable for the study as judged by Investigator.

E.5 End points

E.5.1

Primary end point(s)

Part A:
Safety will be assessed by occurrence and frequency of AEs, SAEs, laboratory parameters, vital signs, ECG and physical examination.

Part B: Safety will be assessed by occurrence and frequency of AEs, SAEs, laboratory parameters, vital signs, ECG and physical examination.

E.5.1.1

Timepoint(s) of evaluation of this end point

Part A: During 24h, 48h and day 8

Part B: During the treatment days and treatment day 7 and day 14 and 14 days after cross over last dose

E.5.2

Secondary end point(s)

Part A: The following PK parameters will be determined: Area under the plasma concentration curve (AUC) 0->∞, AUCt, maximum concentration (Cmax), time to maximum concentration (Tmax), lambdaz, terminal half-life (T1/2), apparent total body clearance following extra vascular administration (CL/F), apparent volume distribution/fraction of drug absorbed (Vz/F).

Part B:
Exposure measured as pre-dose values (Cmin) of GR3027 at steady state.

The following efficacy end points will be used to address the efficacy objective:
- Change in Epworth Sleepiness Scale (ESS) from baseline to week 2 of each treatment period while taking placebo versus GR3027.
- Change in Maintenance of Wakefulness Test (MWT) from baseline to week 2 of each treatment period while taking placebo versus GR3027.

E.5.2.1

Timepoint(s) of evaluation of this end point

Part A: During 24h and 48h

Part B:
• PK results Cmin in week 2 of each treatment period
• Efficacy end point change from baseline to week 2 of each treatment period

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Part A is an open, single dose study. Part B is randomised, double blind, cross over study.

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LSLV

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Standard care as per local country.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-08-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-07-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-10-19

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