adrenoleukodystrophy and Friedreich's ataxia ALD and Friedreich's ataxia
Conditions
Interventions
Only for Part A: 1x 180 mg 14C-leriglitazone will be given as cloudy drink
(oral suspension).
Only for Part B: 1x 180 mg leriglitazone will be given as cloudy drink (oral
suspension). Then after 1.
Sponsors
Minoryx Therapeutics S.L.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Sex: male. 2. Age: 18 to 55 years, inclusive, at screening. 3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening. 4. Status: healthy subjects. 5. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence, in accordance with the lifestyle of the subject, is also acceptable. Further criteria apply.
Exclusion criteria
Exclusion criteria: 1. Employee of contract research organization (CRO) or the Sponsor. 2. Evidence of clinically relevant pathology. 3. Known Type 1 or Type 2 diabetes. 4. Previous or current history of cancer (other than treated basal cell carcinoma). 5. Current suicidal ideation with an intention or plan to act, or a previous suicide attempt. Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, clinical laboratory (clinical chemistry, hematology, and urinalysis), vital signs (systolic and diastolic blood pressure, pulse, body temperature, and respiratory rate), 12-lead electrocardiogram (heart rate, PR interval, QRS-duration, QT-interval, and QTcF-interval), and physical examination. | — |
Countries
Netherlands
Outcome results
None listed