A 2-part, randomized, double-blind, placebo-controlled, sequential group, dose-escalation study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of GLPG2737 in healthy male sub.

Completed

• Conditions: 10027664; Cystic fybrosis; Mucoviscidosis

• Registration Number: NL-OMON42886
• Lead Sponsor: Galapagos SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

Healthy Males between 18-50 years of age, inclusive,
body mass index (BMI) between 18-30 kg/m2, inclusive
Non-smokers and non-users of any nicotine-containing products

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/Aids. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from start of the study. In case of donating more than 100 milliliters of blood in the 12 weeks prior start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To evaluate the safety and tolerability of single ascending oral doses (SAD)<br /><br>of GLPG2737 given to healthy male subjects, compared to placebo.<br /><br>- To evaluate the safety and tolerability of multiple ascending oral doses<br /><br>(MAD) of GLPG2737 given to healthy male subjects daily for 14 days, compared to<br /><br>placebo.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To characterize the PK of GLPG2737 and its metabolites (G1125498 and<br /><br>G1123541) after single and multiple oral administrations.<br /><br>- To evaluate the potential of interaction with cytochrome P450 (CYP) 3A4 after<br /><br>repeated dosing with GLPG2737.</p><br>