First-in-Human Single and Multiple Dose of GLPG1690

Healthy Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG1690 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02179502
• Other study ID #: GLPG1690-CL-101
• Secondary ID: 2014-000981-23
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2014
• Last updated: September 20, 2015
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• 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 First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 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 GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo.

The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690.

Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 will be explored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• 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:
• GLPG1690 single ascending doses
Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg
• Placebo single ascending doses
Single dose, oral suspension or solid formulation matching placebo
• GLPG1690, multiple ascending doses, oral suspension
Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg
• Placebo, multiple ascending doses, oral suspension
Multiple doses, daily for 14 days, oral suspension matching 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
Primary	Number of subjects with adverse events	To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of adverse events	Between screening and 7-10 days after the last dose	Yes
Primary	Number of subjects with abnormal laboratory parameters	To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after single and multiple oral dose in healthy subjects in terms of abnormal laboratory parameters	Between screening and 7-10 days after the last dose	Yes
Primary	Number of subjects with abnormal vital signs	To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal vital signs	Between screening and 7-10 days after the last dose	Yes
Primary	Number of subjects with abnormal electrocardiogram	To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal electrocardiogram	Between screening and 7-10 days after the last dose	Yes
Primary	Number of subjects with abnormal physical examination	To evaluate the safety and tolerability of GLPG1690 in comparison with placebo after a single and multiple oral dose in healthy subjects in terms of abnormal physical examination	Between screening and 7-10 days after the last dose	Yes
Secondary	The amount of GLPG1690 in plasma	To characterize the amount of GLPG1690 in plasma over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation	Between Day 1 predose and 48 hours after the (last) dose	No
Secondary	The amount of GLPG1690 in urine	To characterize the amount of GLPG1690 in urine over time - pharmacokinetics (PK) - after a single and multiple oral dose in healthy subjects, either as liquid or solid formulation	Between Day 1 predose and 24 hours after the (last) dose	No
Secondary	Ratio of 6-b-hydroxycortisol/cortisol in urine	To assess the potential of CYP3A4 induction after repeated dosing with GLPG1690 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine	Twelve hours before dosing on Day 1 and Day 14	No
Secondary	Levels of biomarker in plasma	To characterize the pharmacodynamics (PD) of GLPG1690 by means of reduction of levels of biomarker by GLPG1690 compared to placebo in plasma after single and multiple oral dose in healthy subjects	Day 1 predose up to 48 hours post (last) dose	No