A Drug-drug Interaction Study Between GLPG1205 and a Cocktail of CYP450 Substrates in Healthy Male Subjects

Healthy Clinical Trial

Official title:

A Phase I, Drug-drug Interaction Study Between Oral Doses of GLPG1205 and a Cocktail of CYP2C9, CYP2C19 and CYP1A2 Substrates in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623296
• Other study ID #: GLPG1205-CL-103
• Secondary ID: 2015-002785-23
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2015
• Last updated: February 21, 2016
• Start date: October 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

This will be a Phase I, randomized, double-blind, placebo-controlled, 2 period cross-over, drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1205 or placebo (daily from Day 1 to Day 12) on a single dose pharmacokinetic profile of a cocktail of CYP450 substrates administered to healthy male subjects. The cocktail of CYP450 substrates will consist of 10 mg warfarin (CYP2C9 substrate), 20 mg omeprazole (CYP2C19 substrate) and 100 mg caffeine (CYP1A2 substrate).

Fourteen healthy male subjects will receive during two treatment periods from Day 1 to Day 12 a daily dose of GLPG1205 or placebo. On Day 13, a single dose of the cocktail of CYP450 substrates will be co-administered either with GLPG1205 or with placebo. The two treatment periods will be separated by a wash-out period of at least 28 days.

Also, the safety and tolerability of multiple oral doses of GLPG1205 administered with or without a cocktail of CYP450 substrates in healthy male subjects will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• 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:

• Poor or moderate metabolizer for CYP2C9 or CYP2C19 as determined by genotyping

• Having a contraindication as indicated in the respective Summary of Product Characteristics (or Package Leaflets) for warfarin, omeprazole or caffeine

• Intake of nutraceuticals within 3 weeks prior to dosing or within 6 times the elimination half life

• Intake of enzyme inducing or enzyme inhibiting drugs within 3 months prior to dosing

• Intake of vitamin K within 3 weeks prior to dosing

• Any condition that might interfere with the procedures or tests in this study

• Drug or alcohol abuse

• Smoking

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG1205
Once daily administration of 2 GLPG1205 capsules from Day 1 to Day 13
• Placebo
Once daily administration of 2 matching placebo capsules from Day 1 to Day 13
• Cocktail of CYP450 substrates
Single administration on Day 13 of cocktail of CYP450 substrates: warfarin tablet, omeprazole capsule and caffeine oral solution

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
Primary	The maximum observed concentration (Cmax) of CYP450 substrates in plasma after multiple oral doses of GLPG1205 or placebo	To characterize the maximum observed concentration (Cmax) of CYP450 substrates in plasma over time after a single dose of a cocktail of CYP450 substrates and multiple doses of GLPG1205 or placebo in healthy male subjects	Between Day 13 and 7 days after the last dose	No
Primary	The time of occurrence of Cmax (tmax) of CYP450 substrates in plasma after multiple oral doses of GLPG1205 or placebo	To characterize the time of occurrence of Cmax (tmax) of CYP450 substrates in plasma after a single dose of a cocktail of CYP450 substrates and multiple doses of GLPG1205 or placebo in healthy male subjects	Between Day 13 and 7 days after the last dose	No
Primary	The area under the plasma concentration versus time curve (AUC) of CYP450 substrates in plasma after multiple oral doses of GLPG1205 or placebo	To characterize the area under the plasma concentration versus time curve (AUC) of CYP450 substrates in plasma after a single dose of a cocktail of CYP450 substrates and multiple doses of GLPG1205 or placebo in healthy male subjects	Between Day 13 and 7 days after the last dose	No
Primary	The apparent terminal half-life (t1/2) of CYP450 substrates in plasma after multiple oral doses of GLPG1205 or placebo	To characterize the apparent terminal half-life (t1/2) of CYP450 substrates in plasma after a single dose of a cocktail of CYP450 substrates and multiple doses of GLPG1205 or placebo in healthy male subjects	Between Day 13 and 7 days after the last dose	No
Primary	The metabolite over parent AUC ratio (R) of CYP450 substrates in plasma after multiple oral doses of GLPG1205 or placebo	To characterize the metabolite over parent AUC ratio (R) of CYP450 substrates in plasma after a single dose of a cocktail of CYP450 substrates and multiple doses of GLPG1205 or placebo in healthy male subjects	Between Day 13 and 7 days after the last dose	No
Secondary	Number of adverse events	To evaluate the safety and tolerability of GLPG1205 after multiple oral doses in healthy male subjects with or without coadministration of a cocktail of CYP450 substrates in terms of the number of adverse events reported	Between Screening and 7 days after the last dosing	Yes
Secondary	Changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature	To evaluate the safety and tolerability of GLPG1205 after multiple oral doses in healthy male subjects with or without coadministration of a cocktail of CYP450 substrates in terms of changes in vital signs as measured by heart rate, blood pressure, respiratory rate and oral body temperature reported	Between Screening and 7 days after the last dosing	Yes
Secondary	Changes in 12-lead ECG measures	To evaluate the safety and tolerability of GLPG1205 after multiple oral doses in healthy male subjects with or without coadministration of a cocktail of CYP450 substrates in terms of changes in 12-ECG measures reported	Between Screening and 7 days after the last dosing	Yes
Secondary	Changes in physical examination measures	To evaluate the safety and tolerability of GLPG1205 after multiple oral doses in healthy male subjects with or without coadministration of a cocktail of CYP450 substrates in terms of changes in physical examination measures reported	Between Screening and 7 days after the last dosing	Yes
Secondary	Changes in blood safety lab parameters	To evaluate the safety and tolerability of GLPG1205 after multiple oral doses in healthy male subjects with or without coadministration of a cocktail of CYP450 substrates in terms of changes in blood safety parameters reported	Between Screening and 7 days after the last dosing	Yes
Secondary	Changes in urine safety lab parameters	To evaluate the safety and tolerability of GLPG1205 after multiple oral doses in healthy male subjects with or without coadministration of a cocktail of CYP450 substrates in terms of changes in urine safety parameters reported	Between Screening and 7 days after the last dosing	Yes