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.

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. - GLPG2737 SAD and MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42886

Enrollment

112

Registered

2016-11-09

Start date

2016-11-25

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic fybrosis Mucoviscidosis

Interventions

Part 1: Group Day Treatment How often A 1 25 milligrams (mg) GLPG2737 or placebo Once B 1 TBD, but not exceeding 75 mg GLPG2737 or placebo Once C 1 TBD, but not exceeding 150 mg GLPG2737 or plac

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
- To evaluate the safety and tolerability of single ascending oral doses (SAD) of GLPG2737 given to healthy male subjects, compared to placebo. - To evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG2737 given to healthy male subjects daily for 14 days, compared to placebo.	—

Secondary

Measure	Time frame
- To characterize the PK of GLPG2737 and its metabolites (G1125498 and G1123541) after single and multiple oral administrations. - To evaluate the potential of interaction with cytochrome P450 (CYP) 3A4 after repeated dosing with GLPG2737.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)