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

Galapagos

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: GLPG0634

Study type: Interventional

Funder types: Industry

Identifiers

NCT02084199

GLPG0634-CL-106

2013-004407-40 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 5 patient groups

Part 1 - Severe renal impairment

Experimental group

Description:

Part 1 - Group 1: subjects with severe renal impairment or end-stage renal disease (ESRD), not on dialysis: Estimated glomerular filtration rate (eGFR) between 15-29 mL/min/1.73 m2 or \<15 mL/min/1.73m² will be administered GLPG0634 100 mg once daily for 10 days

Treatment:

Drug: GLPG0634

Part 1: Normal renal function

Experimental group

Description:

Part 1 - Group 2: subjects with normal renal function: eGFR ≥90 mL/min/1.73m² will be administered GLPG0634 100 mg once daily for 10 days

Treatment:

Drug: GLPG0634

Part 2 - Mild renal impairment

Experimental group

Description:

Part 2 - Group 3: subjects with mild renal impairment: eGFR between 60-89 mL/min/1.73 m² will be administered GLPG0634 100 mg once daily for 10 days

Treatment:

Drug: GLPG0634

Part 2 - Moderate renal impairment

Experimental group

Description:

Part 2 - Group 4:subjects with moderate renal impairment: eGFR between 30-59 mL/min/1.73 m² will be administered GLPG0634 100 mg once daily for 10 days

Treatment:

Drug: GLPG0634

Part 2 - Normal renal function

Experimental group

Description:

Part 2 - Group 5: subjects with normal renal function: eGFR ≥90 mL/min/1.73 m² will be administered GLPG0634 100 mg once daily for 10 days

Treatment:

Drug: GLPG0634