sleep disorder Sleep apnea
Conditions
Interventions
GAL-475 capsules or matching placebo.
Sponsors
Neurim Pharmaceuticals Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Part 1: Healthy male subjects aged from 18 to 55 years old, inclusive, at Screening. 2. Part 2: Male subjects with confirmed moderate to severe (AHI >=20) central sleep apnea or mixed sleep apnea diagnosis aged from 18 to 80 years old, inclusive, at Screening. The inclusion of patients with a cerebrovascular accident (CVA) is allowed if these patients have been stabilized, with no episodes occurring, as judged by the principal investigator for at least 3 years prior to screening. Furthermore, upon discretion of the investigator, cardiovascular patients may be included if they: a. Have no history of hospital admission for the last 6 months prior to screening. b. Have had a stable cardiovascular disease/condition for the last 3 years prior to screening. c. Have been on a stable regimen of medication for the last 6 months prior to screening. Upon discretion of the investigator, diabetes type 2 patients and patients with (stable) high blood pressure may also be included if they have been on a stable treatment regimen for at least 3 months prior to screening. 3. Part 2: Documented Continuous Positive Airway Pressure (CPAP) intolerance or CPAP-naïve. 4. Part 2: patients with documented Continuous Positive Airway Pressure (CPAP) poor compliance (poor compliance is defined as self-reported use of CPAP of less than 4 hours per night for less than 70% of nights) are eligible only if CPAP is not used at all for 4 weeks prior to the screening.
Exclusion criteria
Exclusion criteria: 1. Subjects with a prior medical history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. 2. In Part 2, subjects suffering from insomnia or other sleep disorder (other than sleep apnea), or subjects that have a medical/psychological condition that may lead to sleep disturbances. 3. In Part 2, subjects with documented CPAP compliance (compliance is defined as self-reported use of CPAP 4 hours per night for 70% of nights). 4. Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT) level >1.5 x upper limit of normal (ULN) at baseline. Out of range values can be repeated once. 5. Donated blood within 90 days prior to study drug administration or donated plasma within 7 days of prior to study drug administration. 6. Use of prescribed or over-the-counter medications within 14 days of study drug administration. Occasional use of paracetamol is allowed in consultation with the Investigator. Use of blood thinners and antihypertensive drugs is allowed if the patient is stabilized on the specific drug dose for at least 3 months prior to screening and if the specific drug does not interfere with the study drug, as judged on a case to case basis by the Principal Investigator. Use of medications for cardiovascular disease is allowed if the patient is stabilized on the specific drug dose for at least 6 months prior to screening and if the specific drug does not interfere with the study drug, as judged on a case by case basis by the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 The following parameters are primary endpoints for healthy subjects: physical examination, AEs, clinical laboratory values, vital signs, respiratory rate, 12-lead ECG, Cmax, tmax, t1/2, AUC0-t, AUC0-inf, Kel, CL/F, Vz/F, Ae(0-48) (Cohort 2 only), Fe(0-48) (Cohort 2 only), urine concentrations of GAL-475 M1 (demethylation) and M2 (depropylation) metabolites (Cohort 2 only). | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 2 The following parameters are secondary endpoints for subjects with sleep apnea: physical examination, AEs, clinical laboratory values, vital signs, AHI score, oxygen saturation, 12-lead ECG, Cmax, tmax, t1/2, AUC0-t, AUC0-inf, Kel, CL/F, and Vz/F. | — |
Countries
Netherlands
Outcome results
None listed