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

A First-in-human Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3667 in Adult, Healthy, Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG3667 oral suspension; Drug: Placebos; Drug: GLPG3667 capsules

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2060
    • SGS Belgium NV - Clinical Pharmacology Unit Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo SAD; Single doses of placebo	Drug: Placebos; Placebo oral suspension
EXPERIMENTAL: GLPG3667 SAD; Single doses of GLPG3667 at up to 6 dose levels in ascending order	Drug: GLPG3667 oral suspension; GLPG3667 oral suspension
EXPERIMENTAL: GLPG3667 MAD; Multiple doses of GLPG3667 at up to 3 dose levels in ascending order, daily for 13 days	Drug: GLPG3667 oral suspension; GLPG3667 oral suspension
PLACEBO_COMPARATOR: Placebo MAD; Multiple doses of placebo	Drug: Placebos; Placebo oral suspension
EXPERIMENTAL: GLPG3667 FE fasted; Single dose of GLPG3667 in fasted state	Drug: GLPG3667 oral suspension; GLPG3667 oral suspension
EXPERIMENTAL: GLPG3667 FE fed; Single dose of GLPG3667 in fed state	Drug: GLPG3667 oral suspension; GLPG3667 oral suspension
EXPERIMENTAL: GLPG3667 oral suspension rBA-FE fed; Single dose of GLPG3667 oral suspension in fed state	Drug: GLPG3667 oral suspension; GLPG3667 oral suspension
EXPERIMENTAL: GLPG3667 capsules rBA-FE fasted; Single dose of GLPG3667 capsules in fasted state	Drug: GLPG3667 capsules; GLPG3667 capsules
EXPERIMENTAL: GLPG3667 capsules rBA-FE fed; Single dose of GLPG3667 capsules in fed state	Drug: GLPG3667 capsules; GLPG3667 capsules

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Galapagos NV

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2019
• Primary Completion (ACTUAL): March 4, 2020
• Study Completion (ACTUAL): July 6, 2020

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (ACTUAL): September 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: GLPG3667-CL-101; 2019-001659-38 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No