Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects

Phase 1CompletedNCT01820806

Lakefront Biotherapeutics NV6 enrolled

Overview

This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg \[14C\]-radiolabeled GLPG0634. The study aims to establish the elimination pathways of GLPG0634 and their relative significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta. Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to GLPG0634 will be evaluated. This study will also provide safety and tolerability information for GLPG0634.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

100 mg dose of [14C] GLPG0634DRUG

Subjects will be dosed with a single oral 100 mg dose of \[14C\] GLPG0634 on one occasion

Eligibility

Sex: MALEMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * male, between 40 and 65 years of age, inclusive * within BMI range 18 to 30 kg/m2, inclusive Exclusion Criteria: * Any condition that might interfere with the procedures or tests in this study * Drug or alcohol abuse * Smoking

Locations (1)

Quotient Clinical

Nottingham, United Kingdom

Outcomes

Primary Outcomes

The amount of total radioactivity in urine and faeces over time after a single dose of radiolabeled GLPG0634

To evaluate the mass balance recovery of total radioactivity in urine, faeces, and urine and faeces combined to determine the elimination pathways and their relative significance after a single dose of radiolabeled GLPG0634

Time frame: Day -1 (pre-dosing) up to Day 10 post dosing

The amount of GLPG0634 and its main metabolites in urine and faeces over time after a single dose of radiolabeled GLPG0634

To evaluate the recovery of GLPG0634 and its main metabolites in urine and faeces after a single dose of radiolabeled GLPG0634 to determine the elimination pathways and their relative significance (excretion and renal clearance)

Time frame: Day -1 (pre-dosing) up to Day 10 post dosing

Identification of metabolites over time in plasma, urine and faeces after a single dose of radiolabeled GLPG0634

Metabolite profiling and identification in plasma, urine and faeces over time after a single dose of radiolabeled GLPG0634

Time frame: Day -1 (pre-dosing) up to Day 10 post dosing

The amount of radioactivity, GLPG0634 and its main metabolites in blood and plasma over time after a single dose of radiolabeled GLPG0634

To characterize the amount of radioactivity, GLPG0634 and its main metabolites in blood and plasma over time after a single dose of radiolabeled GLPG0634

Time frame: Day 1 (pre-dosing) up to Day 8 post dosing

Secondary Outcomes

Number of adverse events

To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of the number of adverse events reported

Time frame: Screening up to Day 10 post dosing

Data from ClinicalTrials.gov

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