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

The study will be divided in two parts.

In Part 1, 3 subjects with severe renal impairment or end-stage renal disease (ESRD) not yet requiring dialysis (Group 1) will be recruited first. Thereafter, 3 subjects with normal renal function (Group 2) will be recruited. If a substantial effect on the PK in renal impaired subjects is observed on Day 10, the sponsor may elect to stop Part 1 of the study without enrolling the complete set of subjects and Part 2 will be initiated. In case no substantial effect on the PK is observed, 3 further subjects in both Group 1 and 2 will be recruited and analysed. If a substantial effect on the PK is observed, the study will proceed to Part 2. Part 2 of the study will not be conducted, if in Part 1 no substantial difference in PK is seen.

In Part 2, Group 3 (mild renal impairment) and Group 4 (moderate renal impairment) will be recruited first. After completion of the mild and moderate impairment groups, Group 5 (normal renal function) will be recruited.

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