Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721980
• Other study ID #: GLPG0974-CL-102
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2012
• Last updated: February 9, 2013
• Start date: October 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG0974

• Placebo

Locations

Country	Name	City	State
Belgium	SGS LSS Clinical Pharmacology Unit Antwerp	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ratio of 6b-hydroxycortisol/cortisol in urine	Potential of CYP3A4 induction by repeated dosing with GLPG0974 will be assessed by means of the ratio of 6b-hydroxycortisol/cortisol in urine	Predose and postdose on Day 1 and Day 13 for 24h	No
Other	Levels of faecal calprotectin in stool	Concentrations of faecal calprotectin will be measured as a pharmacodynamic marker in a single stool sample predose and postdose	Prior to first dosing and postdose (between Day 12 and 15)	No
Other	Glucose and insulin concentrations after glucose loading	Oral glucose tolerance test by means of measuring concentrations of glucose and insulin after glucose loading, once predosing and once postdosing of GLPG0974	Day -1 (predose) and Day 14 (postdose)	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	No