Multiple Ascending Dose Study of GLPG0492 in Healthy Subjects

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0492; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01397370

2010-024039-18 (EudraCT Number)

GLPG0492-CL-102

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0492 given to healthy subjects for 14 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after multiple oral administrations.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male, age 18-50 years
• body mass index (BMI) between 18-29.9 kg/m², inclusive.
• normal values of testosterone (2.49-8.36 ng/mL) and LH (1.7-8.6 U/L)

Exclusion criteria

• smoking
• drug or alcohol abuse
• hypersensitivity to any of the ingredients of the study drug

Trial design

24 participants in 2 patient groups, including a placebo group

GLPG0492 oral solution

Experimental group

Description:

Multiple ascending doses once daily for 14 days, starting from 5 mg/day

Treatment:

Drug: GLPG0492

Placebo oral solution

Placebo Comparator group

Description:

Once daily dosing for 14 days

Treatment:

Drug: Placebo