GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study

Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0778 in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01336244

Enrollment

Registered

2011-04-15

Start date

2011-04-30

Completion date

2011-09-30

Last updated

2011-10-18

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 multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.

Interventions

DRUGGLPG0778

capsules containing 50 or 100 mg of GLPG0778

DRUGplacebo

multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy male, age 18-50 years * body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion criteria

* significantly abnormal platelet function or coagulopathy * smoking * drug or alcohol abuse * hypersensitivity to any of the test substances

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of hematological, biochemical and cardiovascular parameters.	until 10 days postdose.	On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation.
Occurrence of adverse events	Daily during treatment, up to 10 days postdose	At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.

Secondary

Measure	Time frame	Description
Pharmacokinetics of repeated doses	24 hours 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).
Pharmacodynamics (PD) of GLPG0778	up to 10 days postdose	To explore biomarkers of GLPG0778 activity after repeated oral administrations.

Countries

Belgium

Outcome results

None listed

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