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.
- Conditions
- Idiopathic hypersomnia (IH)MedDRA version: 20.0Level: HLTClassification code 10028714Term: Narcolepsy and hypersomniaSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-002127-16-FI
- Lead Sponsor
- mecrine Cognition AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method