First-in-Human Single and Multiple Dose of GLPG1205

G

Galapagos

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Placebo, multiple ascending doses, oral suspension
Drug: GLPG1205, multiple ascending doses, oral suspension
Drug: GLPG1205 single ascending doses, oral suspension
Drug: Placebo single ascending doses, oral suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT01887106
GLPG1205-CL-101

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 4 patient groups, including a placebo group

GLPG1205 single dose
Experimental group
Description:
Single oral dose of GLPG1205 suspension - ascending doses
Treatment:
Drug: GLPG1205 single ascending doses, oral suspension
Placebo single dose
Placebo Comparator group
Description:
Single oral dose of placebo suspension
Treatment:
Drug: Placebo single ascending doses, oral suspension
GLPG1205 multiple doses
Experimental group
Description:
Multiple oral doses of GLPG1205 suspension - ascending doses
Treatment:
Drug: GLPG1205, multiple ascending doses, oral suspension
Placebo multiple doses
Placebo Comparator group
Description:
Multiple oral doses of placebo suspension
Treatment:
Drug: Placebo, multiple ascending doses, oral suspension

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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