Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0974; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01721980

GLPG0974-CL-102

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability after multiple ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.

Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo.

Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.

Enrollment: 32 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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32 participants in 4 patient groups

50 mg GLPG0974 or placebo

Other group

Description:

50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days

Treatment:

Drug: Placebo

Drug: GLPG0974

100 mg GLPG0974 or placebo

Other group

Description:

100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days

Treatment:

Drug: Placebo

Drug: GLPG0974

200 mg GLPG0974 or placebo

Other group

Description:

200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days

Treatment:

Drug: Placebo

Drug: GLPG0974

400 mg GLPG0974 or placebo

Other group

Description:

400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days

Treatment:

Drug: Placebo

Drug: GLPG0974