Trials / Terminated
TerminatedNCT04575818
A Study in Healthy Male Volunteers Investigating the Safety, Absorption and Elimination of Single Doses of GLPG4059
A First-in-human, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of GLPG4059 in Adult, Healthy, Male Subjects
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Galapagos NV · Industry
- Sex
- Male
- Age
- 18 Years – 54 Years
- Healthy volunteers
- Accepted
Summary
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GLPG4059 in healthy volunteers after single oral administrations of GLPG4059 (SAD), compared to placebo (part 1). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics and relative bioavailability (rBA) of GLPG4059 will be assessed (part 2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GLPG4059 oral suspension | GLPG4059 for oral administration |
| DRUG | Placebo | Placebo oral suspension |
| DRUG | GLPG4059 tablet | GLPG4059 for oral administration |
Timeline
- Start date
- 2020-09-16
- Primary completion
- 2021-04-08
- Completion
- 2021-04-08
- First posted
- 2020-10-05
- Last updated
- 2021-05-11
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04575818. Inclusion in this directory is not an endorsement.