NCT01278108

First-in-Human Single Ascending and Multiple Dose of GLPG0778

Double-blind, Placebo-controlled, Dose-ranging Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Oral Doses, and Multiple Oral Doses of GLPG0778 in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food). Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG0778	single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose)
DRUG	placebo	single dose, oral solution or capsule (matching corresponding study medication)
DRUG	GLPG0778	multiple dose, capsule, 7 days
DRUG	placebo	multiple dose, capsule, 7 days

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-02-01
• Completion: 2011-05-01
• First posted: 2011-01-17
• Last updated: 2011-10-18

Locations

1 site across 1 country: Belgium