Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects

NCT01721980 | Completed Phase 1

• 1 other identifier: GLPG0974-CL-102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The amount of GLPG0974 in plasma and urine over time after multiple oral dose

  Between Day 1 predose and Day 14

• Inhibition of CD11b on neutrophils in blood after multiple oral doses of GLPG0974

  Day 1 and Day 13, predose until 24h post dose

Other Outcomes (3)

• Ratio of 6b-hydroxycortisol/cortisol in urine

  Predose and postdose on Day 1 and Day 13 for 24h

• Levels of faecal calprotectin in stool

  Prior to first dosing and postdose (between Day 12 and 15)

• Glucose and insulin concentrations after glucose loading

  Day -1 (predose) and Day 14 (postdose)

Study Arms (4)

50 mg GLPG0974 or placebo

OTHER

50 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days

Drug: GLPG0974; Drug: Placebo

100 mg GLPG0974 or placebo

OTHER

100 mg GLPG0974 dose as oral capsule or placebo oral capsule, daily for 14 days

Drug: GLPG0974; Drug: Placebo

200 mg GLPG0974 or placebo

OTHER

200 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days

Drug: GLPG0974; Drug: Placebo

400 mg GLPG0974 or placebo

OTHER

400 mg GLPG0974 dose as oral capsule or placebo capsule, daily for 14 days

Drug: GLPG0974; Drug: Placebo

Interventions

GLPG0974 DRUG

100 mg GLPG0974 or placebo; 200 mg GLPG0974 or placebo; 400 mg GLPG0974 or placebo; 50 mg GLPG0974 or placebo

Placebo DRUG

100 mg GLPG0974 or placebo; 200 mg GLPG0974 or placebo; 400 mg GLPG0974 or placebo; 50 mg GLPG0974 or placebo

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

4-(((R)-1-(benzo(b)thiophene-3-carbonyl)-2-methyl-azetidine-2-carbonyl)-(3-chloro-benzyl)-amino)-butyric acid

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: November 2, 2012
• First Posted: November 6, 2012
• Study Start: October 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

BE (1)