A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG3667 oral suspension; Drug: GLPG3667 capsules; Drug: Placebos

• Registration Number: NCT04097938
• Lead Sponsor: Galapagos NV

Brief Summary

This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-18
• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Primary Completion: 2020-03-04
• Status Verified: 2020-07
• Study Completion: 2020-07-06
• Last Update Submitted: 2020-07-16
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

Inclusion Criteria

• Male between 18-55 years of age (extremes included), on the date of signing the informed consent form (ICF)
• A body mass index (BMI) between 18-30 kg/m2, inclusive
• Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal ranges. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator

Exclusion Criteria

• Known hypersensitivity to Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator
• Known contraindication or hypersensitivity to Interferon-alpha (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part)
• Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IMP.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GLPG3667 SAD	GLPG3667 oral suspension	Single doses of GLPG3667 at up to 6 dose levels in ascending order
GLPG3667 capsules rBA-FE fasted	GLPG3667 capsules	Single dose of GLPG3667 capsules in fasted state
GLPG3667 FE fed	GLPG3667 oral suspension	Single dose of GLPG3667 in fed state
GLPG3667 oral suspension rBA-FE fed	GLPG3667 oral suspension	Single dose of GLPG3667 oral suspension in fed state
GLPG3667 capsules rBA-FE fed	GLPG3667 capsules	Single dose of GLPG3667 capsules in fed state
Placebo SAD	Placebos	Single doses of placebo
GLPG3667 FE fasted	GLPG3667 oral suspension	Single dose of GLPG3667 in fasted state
GLPG3667 MAD	GLPG3667 oral suspension	Multiple doses of GLPG3667 at up to 3 dose levels in ascending order, daily for 13 days
Placebo MAD	Placebos	Multiple doses of placebo

Primary Outcome Measures

Name	Time	Method
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations	From screening through study completion, an average of 5 months	To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo

Secondary Outcome Measures

Name	Time	Method
Area under curve (AUC) of GLPG3667 (μg.h/mL)	Between Day 1 pre-dose and Day 16	To evaluate the PK of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects
Maximum observed plasma concentration (Cmax) of GLPG3667 (μg/mL)	Between Day 1 pre-dose and Day 16	To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects
Terminal elimination half-life (t1/2) of GLPG3667 (h)	Between Day 1 pre-dose and Day 16	To evaluate the PK of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects

Trial Locations

Locations (1)

SGS Belgium NV - Clinical Pharmacology Unit Antwerp; 🇧🇪 Antwerp, Belgium