First-in-Human Single Ascending and Multiple Dose of GLPG0634

Double-blind Placebo-controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG0634 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01179581

Enrollment

Registered

2010-08-11

Start date

2010-08-31

Completion date

2011-03-31

Last updated

2011-03-24

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

Conditions

Healthy

Keywords

Safety, Tolerability, Pharmacokinetics

Brief summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food). Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Interventions

DRUGGLPG0634

single ascending doses, oral solution (1 to 10 mg/dose) and capsules (10 to 200 mg/dose)

DRUGplacebo

single dose, oral solution or capsule (matching corresponding study medication)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

40 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy male, age 40-60 years * body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion criteria

* any condition that might interfere with the procedures or tests in the study * smoking * drug or alcohol abuse

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of single and multiple dosing	up to 10 days postdose	Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and bloodcirculation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study.

Secondary

Measure	Time frame	Description
Pharmacokinetics of single and repeated doses, including effect of food.	up to 10 days postdose	Bloodsamples are taken on various timepoints to assess how much of the study drug is taken up in the blood (absorption), how long it stays in the blood (excretion), and whether any breakdown-products of the drug are present (metabolism).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026