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Completed

NCT Number: NCT01820806

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

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.

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Key information

Conditions

Healthy

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

100 mg dose of [14C] GLPG0634

Drug

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

Primary outcomes

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

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

    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

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

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

    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)

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

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

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

  4. 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

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

Secondary outcomes

  1. Number of adverse events

    Time frame: Screening up to Day 10 post dosing

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

  2. Changes in vital signs as measured by heart rate, blood pressure and oral temperature

    Time frame: Screening up to Day 10 post dosing

    To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in vital signs as measured by heart rate, blood pressure and oral temperature reported

  3. Changes in 12-lead ECG measures

    Time frame: Screening up to Day 10 post dosing

    To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in 12-ECG measures reported

  4. Changes in physical exam measures

    Time frame: Screening up to Day 10 post dosing

    To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in physical exam measures reported

  5. Changes in blood safety lab parameters

    Time frame: Screening up to Day 10 post dosing

    To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in blood safety lab parameters reported

  6. Changes in urine safety lab parameters

    Time frame: Screening up to Day 10 post dosing

    To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in urine safety lab parameters reported

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects Following a Single Oral Administration of [14C] GLPG0634

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 29, 2013
Registry last updated
May 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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