A phase 1, open-label, single-center study of absorption, metabolism and excretion and absolute bioavailability in humans of leriglitazone (MIN-102) in 2 parallel cohorts of male healthy subjects

Completed

Conditions: adrenoleukodystrophy and Friedreich's ataxia
ALD and Friedreich's ataxia
10007951

Registration Number: NL-OMON51365

Lead Sponsor: Minoryx Therapeutics S.L.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adverse events, clinical laboratory (clinical chemistry, hematology, and<br /><br>urinalysis), vital signs (systolic and diastolic blood pressure, pulse, body<br /><br>temperature, and respiratory rate), 12-lead electrocardiogram (heart rate, PR<br /><br>interval, QRS-duration, QT-interval, and QTcF-interval), and physical<br /><br>examination.</p><br>

Secondary Outcome Measures