Idiopathic hypersomnia (IH) MedDRA version: 20.0 Level: HLT Classification code 10028714 Term: Narcolepsy and hypersomnia System Organ Class: 100000004852
Conditions
Interventions
Product Code: GR3027
Pharmaceutical Form: Capsule
INN or Proposed INN: Not yet available
CAS Number: 2089238-18-4
Current Sponsor code: GR3027
Other descriptive name: GR3027
Concentration unit: mg mil
Sponsors
Umecrine Cognition AB
Eligibility
Sex/Gender
All
Inclusion criteria
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) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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. ;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. ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A: The following PK parameters will be determined: Area under the plasma concentration curve (AUC) 0->8, 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.;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 | — |
Countries
Denmark, Finland, Sweden
Contacts
Public ContactChief Executive Officer
Umecrine Cognition AB
Outcome results
None listed