A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First in Man, Single Escalating Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GAL-475 in Healthy Male Volunteers and Male Subjects with Sleep Apnea
- Conditions
- sleep disorderSleep apnea
- Registration Number
- NL-OMON55229
- Lead Sponsor
- eurim Pharmaceuticals Ltd.
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1<br /><br>The following parameters are primary endpoints for healthy subjects: physical<br /><br>examination, AEs, clinical laboratory values, vital signs, respiratory rate,<br /><br>12-lead ECG, Cmax, tmax, t1/2, AUC0-t, AUC0-inf, Kel, CL/F, Vz/F, Ae(0-48)<br /><br>(Cohort 2 only), Fe(0-48) (Cohort 2 only), urine concentrations of GAL-475 M1<br /><br>(demethylation) and M2 (depropylation) metabolites<br /><br>(Cohort 2 only).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part 2<br /><br>The following parameters are secondary endpoints for subjects with sleep apnea:<br /><br>physical examination, AEs, clinical laboratory values, vital signs, AHI score,<br /><br>oxygen saturation, 12-lead ECG, Cmax, tmax, t1/2, AUC0-t, AUC0-inf, Kel, CL/F,<br /><br>and Vz/F.</p><br>