Study to Evaluate GLPG0634 in Subjects With Renal Impairment Compared to Healthy Subjects

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be an open label study to assess the influence of renal impairment on the pharmacokinetics (PK) of GLPG0634 and its metabolite after once daily oral administrations of 100 mg GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls.

Also, safety and tolerability of once daily oral doses of GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls will be evaluated.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Galapagos NV

Criteria

Inclusion Criteria:

• Male and female white subjects between 18-79 years of age (inclusive)

• Subjects must have a BMI between 18-34 kg/m², inclusive

• Part 1, Group 1: subject with severe renal impairment or ESRD, not on dialysis : eGFR between 15-29 mL/min/1.73 m2 or <15 mL/min/1.73m²

• Part 1, Group 2: subject with normal renal function: eGFR ≥90 mL/min/1.73m²

• Part 2, Group 3: subject with mild renal impairment: eGFR between 60-89 mL/min/1.73 m²

• Part 2, Group 4:subject with moderate renal impairment: eGFR between 30-59 mL/min/1.73 m²

• Part 2, Group 5: subject with normal renal function: eGFR ≥90 mL/min/1.73 m²

• Subjects must be judged to be in good health (subjects with normal renal function)/in a stable condition and acceptable for study participation (subjects with renal impairment) based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and laboratory profile

Exclusion Criteria:

• A subject with a known hypersensitivity to ingredients of the study medication or a significant allergic reaction to any drug

• Subject has previously participated in a GLPG0634 study or has previously received GLPG0634

• Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study

• A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration

• A subject who has a current child wish

• Female subject less than 6 months post-partum, post-abortion or post-lactation prior to study drug administration or is pregnant or breastfeeding