First-in-Human Single and Multiple Dose of GLPG1205

NCT01887106 | Completed Phase 1

• 1 other identifier: GLPG1205-CL-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability after single dose

  To evaluate the safety and tolerability of GLPG1205 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

• Safety and tolerability after multiple doses

  To evaluate the safety and tolerability of GLPG1205 in comparison with placebo after multiple oral doses daily for 14 days 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 Outcomes (5)

• The amount of GLPG1205 in plasma and urine over time after a single oral dose

  Between Day 1 predose and 48 hours post dose

• The amount of GLPG1205 in plasma and urine over time after multiple oral doses

  Between Day 1 predose and Day 16 (48 hours after the last dose)

• Ratio of 6-b-hydroxycortisol/cortisol in urine

  Twelve hours before dosing on Day 1 and Day 14

• Receptor occupancy by GLPG1205 on blood cells after a single dose

  Day 1 predose up to 24 hours post dose

• Receptor occupancy by GLPG1205 on blood cells after multiple doses

  Day 1 and Day 14, predose up to 24 hours post dose

Study Arms (4)

GLPG1205 single dose

EXPERIMENTAL

Single oral dose of GLPG1205 suspension - ascending doses

Drug: GLPG1205 single ascending doses, oral suspension

Placebo single dose

PLACEBO COMPARATOR

Single oral dose of placebo suspension

Drug: Placebo single ascending doses, oral suspension

GLPG1205 multiple doses

EXPERIMENTAL

Multiple oral doses of GLPG1205 suspension - ascending doses

Drug: GLPG1205, multiple ascending doses, oral suspension

Placebo multiple doses

PLACEBO COMPARATOR

Multiple oral doses of placebo suspension

Drug: Placebo, multiple ascending doses, oral suspension

Interventions

GLPG1205 single ascending doses, oral suspension DRUG

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

GLPG1205 single dose

Placebo single ascending doses, oral suspension DRUG

Single dose, oral suspension matching placebo

Placebo single dose

GLPG1205, multiple ascending doses, oral suspension DRUG

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

GLPG1205 multiple doses

Placebo, multiple ascending doses, oral suspension DRUG

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

Placebo multiple doses

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Location

MeSH Terms

Interventions

Suspensions; GLPG1205

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Frédéric Vanhoutte, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2013
• First Posted: June 26, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

BE (1)