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

Phase 1CompletedNCT02084199

Lakefront Biotherapeutics NV24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

GLPG0634DRUG

100 mg oral tablet, intake once daily for 10 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CRS Clinical Research Services Kiel GmbH

Kiel, Germany

Outcomes

Primary Outcomes

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

Time frame: 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

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

Secondary Outcomes

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

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

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

Renal clearance (CLR)

CLR (calculated as Ae/AUC, where Ae and AUC are calculated over the same interval) of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function

Time frame: 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)

C24h of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function

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

Average plasma concentration (Cavg)

Cavg (calculated as AUC0-24h/24h) of GLPG0634 and its metabolite after single and multiple dosing in subjects with renal impairment versus subjects with normal renal function

Data from ClinicalTrials.gov

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