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

NCT02084199 | Completed Phase 1

• 2 other identifiers: GLPG0634-CL-1062013-004407-40
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (2)

• Maximum observed plasma concentration (Cmax)

  Cmax of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function

  Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)

• Area under the plasma drug concentration-time curve over 24 hours (AUC0-24h)

  AUC0-24h of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function

  Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)

Secondary Outcomes (15)

• Cumulative amount excreted in urine expressed in μg and % of the dose administered (Ae)

  Between dosing on Day 1 up to 48 h after dosing on Day 10 (Day 12)

• Renal clearance (CLR)

  Between dosing on Day 1 up to 48 h after dosing on Day 10 (Day 12)

• Plasma concentration observed at 24 h post-dose (C24h)

  Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)

• Average plasma concentration (Cavg)

  Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)

• Time of occurrence of Cmax (tmax)

  Between Day 1 at pre-dose up to 168 h after the last dose on Day 10 (Day 17)

Study Arms (5)

Part 1 - Severe renal impairment

EXPERIMENTAL

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

Drug: GLPG0634

Part 1: Normal renal function

EXPERIMENTAL

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

Drug: GLPG0634

Part 2 - Mild renal impairment

EXPERIMENTAL

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

Drug: GLPG0634

Part 2 - Moderate renal impairment

EXPERIMENTAL

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

Drug: GLPG0634

Part 2 - Normal renal function

EXPERIMENTAL

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

Drug: GLPG0634

Interventions

GLPG0634 DRUG

100 mg oral tablet, intake once daily for 10 days

Also known as: GLPG0634 tablets

Part 1 - Severe renal impairment; Part 1: Normal renal function; Part 2 - Mild renal impairment; Part 2 - Moderate renal impairment; Part 2 - Normal renal function

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

CRS Clinical Research Services Kiel GmbH

Kiel, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Pille Harrison, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2014
• First Posted: March 11, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

DE (1)