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

NCT ID: NCT02084199

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-07-31

Brief 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.

Detailed 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.

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1 - Severe renal impairment

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

Group Type: EXPERIMENTAL

GLPG0634

Intervention Type: DRUG

100 mg oral tablet, intake once daily for 10 days

Part 1: Normal renal function

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

Group Type: EXPERIMENTAL

GLPG0634

Intervention Type: DRUG

100 mg oral tablet, intake once daily for 10 days

Part 2 - Mild renal impairment

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

Group Type: EXPERIMENTAL

GLPG0634

Intervention Type: DRUG

100 mg oral tablet, intake once daily for 10 days

Part 2 - Moderate renal impairment

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

Group Type: EXPERIMENTAL

GLPG0634

Intervention Type: DRUG

100 mg oral tablet, intake once daily for 10 days

Part 2 - Normal renal function

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

Group Type: EXPERIMENTAL

GLPG0634

Intervention Type: DRUG

100 mg oral tablet, intake once daily for 10 days

Interventions

GLPG0634

100 mg oral tablet, intake once daily for 10 days

Intervention Type: DRUG

Other Intervention Names

GLPG0634 tablets

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pille Harrison, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

CRS Clinical Research Services Kiel GmbH

Kiel, , Germany

Countries

Germany

Other Identifiers

2013-004407-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG0634-CL-106

Identifier Type: -

Identifier Source: org_study_id