Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability after multiple ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo. Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo. Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.

Official Title
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Double-blind, Randomized, Placebo-controlled Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0974 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG0974
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 50 mg GLPG0974 or placebo<br>50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days | Drug: GLPG0974<br> <br> Drug: Placebo<br> <br> |
| Other: 100 mg GLPG0974 or placebo<br>100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days | Drug: GLPG0974<br> <br> Drug: Placebo<br> <br> |
| Other: 200 mg GLPG0974 or placebo<br>200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days | Drug: GLPG0974<br> <br> Drug: Placebo<br> <br> |
| Other: 400 mg GLPG0974 or placebo<br>400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days | Drug: GLPG0974<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | To evaluate the safety and tolerability of GLPG0974 in comparison with placebo after a single oral dose in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments | Between screening and 7-10 days after the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of GLPG0974 in plasma and urine over time after multiple oral dose | To characterize the amount of GLPG0974 in plasma and urine over time - pharmacokinetics (PK) - after multiple oral doses in healthy subjects | Between Day 1 predose and Day 14 | 
| Inhibition of CD11b on neutrophils in blood after multiple oral doses of GLPG0974 | To characterize the pharmacodynamics (PD) of GLPG0974 by means of inhibition of expression of CD11b on neutrophils after multiple oral doses in healthy subjects | Day 1 and Day 13, predose until 24h post dose |