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First-in-Human Single Ascending and Multiple Dose of GLPG0778

NCT ID: NCT01278108

Last Updated: 2011-10-18

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

2010-12-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

single ascending doses

Group Type EXPERIMENTAL

GLPG0778

Intervention Type DRUG

single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose)

2

single dose placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

single dose, oral solution or capsule (matching corresponding study medication)

3

multiple dose, 7 days, capsules (dosing depends on outcome of single-dose part; can be once or twice daily).

Group Type EXPERIMENTAL

GLPG0778

Intervention Type DRUG

multiple dose, capsule, 7 days

4

multiple dose, capsules, 7 days; scheme to match that of Study Arm 3.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

multiple dose, capsule, 7 days

Interventions

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GLPG0778

single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose)

Intervention Type DRUG

placebo

single dose, oral solution or capsule (matching corresponding study medication)

Intervention Type DRUG

GLPG0778

multiple dose, capsule, 7 days

Intervention Type DRUG

placebo

multiple dose, capsule, 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy male
* body mass index (BMI) between 18-30 kg/m², inclusive.

Exclusion Criteria

* any condition that might interfere with the procedures or tests in the study
* smoking
* drug or alcohol abuse
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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Gerben van 't Klooster, PhD

Role: STUDY_DIRECTOR

Galapagos NV

Lien Gheyle, MD

Role: PRINCIPAL_INVESTIGATOR

SGS Stuivenberg

Locations

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SGS Stuivenberg

Antwerp, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2010-023199-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG0778-CL-101

Identifier Type: -

Identifier Source: org_study_id