A phase 1, randomized, double-blind, placebo-controlled, single-site study to assess the safety, tolerability, pharmacokinetics and food effect of MIN-102 following oral administration of single and multiple ascending doses in healthy male volunteers

Completed

• Conditions: metabolic disorder; X-linked adrenoleukodystrophy; 10000546

• Registration Number: NL-OMON42947
• Lead Sponsor: Minoryx Therapeutics S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

healthy male volunteers
18 - 55 yrs, inclusive
BMI: 18.0 - 28.0 kg/m2, inclusive
non-smoking

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS.
Participation in a drug study within 90 days prior to the first drug administration in the current study. Participation in more than 3 other drug studies (for male subjects) in the 10 months prior to (the first) drug administration in the current study.
Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects) in the 10 months prior to (the first) drug administration in the current study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part A:<br /><br>To evaluate the safety and tolerability of MIN-102 administered orally as a<br /><br>single dose in healthy male volunteers.<br /><br><br /><br>Part B:<br /><br>To evaluate the safety and tolerability of MIN-102 administered orally as a<br /><br>multiple dose in healthy male volunteers.<br /><br><br /><br>Part C:<br /><br>To evaluate the safety and tolerability of MIN-102 administered orally as a<br /><br>multiple dose in healthy male volunteers.</p><br>