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

NCT04097938 | Completed Phase 1

• 2 other identifiers: GLPG3667-CL-1012019-001659-38
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maximum observed plasma concentration (Cmax) of GLPG3667 (μg/mL)

  Between Day 1 pre-dose and Day 16

• Area under curve (AUC) of GLPG3667 (μg.h/mL)

  Between Day 1 pre-dose and Day 16

• Terminal elimination half-life (t1/2) of GLPG3667 (h)

  Between Day 1 pre-dose and Day 16

Study Arms (9)

GLPG3667 SAD

EXPERIMENTAL

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

Drug: GLPG3667 oral suspension

Placebo SAD

PLACEBO COMPARATOR

Single doses of placebo

Drug: Placebos

GLPG3667 MAD

EXPERIMENTAL

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

Drug: GLPG3667 oral suspension

Placebo MAD

PLACEBO COMPARATOR

Multiple doses of placebo

Drug: Placebos

GLPG3667 FE fasted

EXPERIMENTAL

Single dose of GLPG3667 in fasted state

Drug: GLPG3667 oral suspension

GLPG3667 FE fed

EXPERIMENTAL

Single dose of GLPG3667 in fed state

Drug: GLPG3667 oral suspension

GLPG3667 oral suspension rBA-FE fed

EXPERIMENTAL

Single dose of GLPG3667 oral suspension in fed state

Drug: GLPG3667 oral suspension

GLPG3667 capsules rBA-FE fasted

EXPERIMENTAL

Single dose of GLPG3667 capsules in fasted state

Drug: GLPG3667 capsules

GLPG3667 capsules rBA-FE fed

EXPERIMENTAL

Single dose of GLPG3667 capsules in fed state

Drug: GLPG3667 capsules

Interventions

GLPG3667 oral suspension DRUG

GLPG3667 oral suspension

GLPG3667 FE fasted; GLPG3667 FE fed; GLPG3667 MAD; GLPG3667 SAD; GLPG3667 oral suspension rBA-FE fed

Placebos DRUG

Placebo oral suspension

Placebo MAD; Placebo SAD

GLPG3667 capsules DRUG

GLPG3667 capsules

GLPG3667 capsules rBA-FE fasted; GLPG3667 capsules rBA-FE fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS Belgium NV - Clinical Pharmacology Unit Antwerp

Antwerp, 2060, Belgium

Location

Study Officials

• Magdalena Petkova, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 20, 2019
• Study Start: September 18, 2019
• Primary Completion: March 4, 2020
• Study Completion: July 6, 2020
• Last Updated: September 19, 2024

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)