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

NCT ID: NCT04097938

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-18
• Study Completion Date: 2020-07-06

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

GLPG3667 SAD

Single doses of GLPG3667 at up to 6 dose levels in ascending order

Group Type: EXPERIMENTAL

GLPG3667 oral suspension

Intervention Type: DRUG

GLPG3667 oral suspension

Placebo SAD

Single doses of placebo

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebo oral suspension

GLPG3667 MAD

Multiple doses of GLPG3667 at up to 3 dose levels in ascending order, daily for 13 days

Group Type: EXPERIMENTAL

GLPG3667 oral suspension

Intervention Type: DRUG

GLPG3667 oral suspension

Placebo MAD

Multiple doses of placebo

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebo oral suspension

GLPG3667 FE fasted

Single dose of GLPG3667 in fasted state

Group Type: EXPERIMENTAL

GLPG3667 oral suspension

Intervention Type: DRUG

GLPG3667 oral suspension

GLPG3667 FE fed

Single dose of GLPG3667 in fed state

Group Type: EXPERIMENTAL

GLPG3667 oral suspension

Intervention Type: DRUG

GLPG3667 oral suspension

GLPG3667 oral suspension rBA-FE fed

Single dose of GLPG3667 oral suspension in fed state

Group Type: EXPERIMENTAL

GLPG3667 oral suspension

Intervention Type: DRUG

GLPG3667 oral suspension

GLPG3667 capsules rBA-FE fasted

Single dose of GLPG3667 capsules in fasted state

Group Type: EXPERIMENTAL

GLPG3667 capsules

Intervention Type: DRUG

GLPG3667 capsules

GLPG3667 capsules rBA-FE fed

Single dose of GLPG3667 capsules in fed state

Group Type: EXPERIMENTAL

GLPG3667 capsules

Intervention Type: DRUG

GLPG3667 capsules

Interventions

GLPG3667 oral suspension

GLPG3667 oral suspension

Intervention Type: DRUG

Placebos

Placebo oral suspension

Intervention Type: DRUG

GLPG3667 capsules

GLPG3667 capsules

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magdalena Petkova, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

SGS Belgium NV - Clinical Pharmacology Unit Antwerp

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

2019-001659-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG3667-CL-101

Identifier Type: -

Identifier Source: org_study_id