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First-in-Human Single and Multiple Dose of GLPG1205

NCT ID: NCT01887106

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo.

Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GLPG1205 single dose

Single oral dose of GLPG1205 suspension - ascending doses

Group Type EXPERIMENTAL

GLPG1205 single ascending doses, oral suspension

Intervention Type DRUG

Single dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg

Placebo single dose

Single oral dose of placebo suspension

Group Type PLACEBO_COMPARATOR

Placebo single ascending doses, oral suspension

Intervention Type DRUG

Single dose, oral suspension matching placebo

GLPG1205 multiple doses

Multiple oral doses of GLPG1205 suspension - ascending doses

Group Type EXPERIMENTAL

GLPG1205, multiple ascending doses, oral suspension

Intervention Type DRUG

Multiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg

Placebo multiple doses

Multiple oral doses of placebo suspension

Group Type PLACEBO_COMPARATOR

Placebo, multiple ascending doses, oral suspension

Intervention Type DRUG

Multiple doses, daily for 14 days, oral suspension matching placebo

Interventions

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GLPG1205 single ascending doses, oral suspension

Single dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg

Intervention Type DRUG

Placebo single ascending doses, oral suspension

Single dose, oral suspension matching placebo

Intervention Type DRUG

GLPG1205, multiple ascending doses, oral suspension

Multiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg

Intervention Type DRUG

Placebo, multiple ascending doses, oral suspension

Multiple doses, daily for 14 days, oral suspension matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Galapagos NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric Vanhoutte, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

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SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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GLPG1205-CL-101

Identifier Type: -

Identifier Source: org_study_id