NL-OMON55229
Completed
Not Applicable
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 - CS0352-200069
eurim Pharmaceuticals Ltd.0 sites36 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- sleep disorder
- Sponsor
- eurim Pharmaceuticals Ltd.
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Part 1: Healthy male subjects aged from 18 to 55 years old, inclusive, at
- •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
- •b. Have had a stable cardiovascular disease/condition for the last 3 years
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).
Outcomes
Primary Outcomes
Not specified
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