First-in-Human Single and Multiple Dose of GLPG1205

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo, multiple ascending doses, oral suspension; Drug: GLPG1205, multiple ascending doses, oral suspension; Drug: GLPG1205 single ascending doses, oral suspension; Drug: Placebo single ascending doses, oral suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01887106

GLPG1205-CL-101

Details and patient eligibility

About

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo.

Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male, age 18-50 years
• BMI between 18-30 kg/m2

Exclusion criteria

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

GLPG1205 single dose

Experimental group

Description:

Single oral dose of GLPG1205 suspension - ascending doses

Treatment:

Drug: GLPG1205 single ascending doses, oral suspension

Placebo single dose

Placebo Comparator group

Description:

Single oral dose of placebo suspension

Treatment:

Drug: Placebo single ascending doses, oral suspension

GLPG1205 multiple doses

Experimental group

Description:

Multiple oral doses of GLPG1205 suspension - ascending doses

Treatment:

Drug: GLPG1205, multiple ascending doses, oral suspension

Placebo multiple doses

Placebo Comparator group

Description:

Multiple oral doses of placebo suspension

Treatment:

Drug: Placebo, multiple ascending doses, oral suspension