A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects

NCT04976270 | Completed Phase 1

• 2 other identifiers: GLPG3667-CL-1182021-002488-23
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667 (part 2) in healthy male subjects.

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 oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo

  From screening through study completion, an average of 3 months

Secondary Outcomes (6)

• Maximum observed plasma concentration (Cmax) of GLPG3667 - SD

  Between Day 1 pre-dose and Day 4

• Maximum observed plasma concentration (Cmax) of GLPG3667 - MD

  Between Day 1 pre-dose and Day 16

• Area under the plasma concentration-time curve (AUC) of GLPG3667 - SD

  Between Day 1 pre-dose and Day 4

• Area under the plasma concentration-time curve (AUC) of GLPG3667 - MD

  Between Day 1 pre-dose and Day 16

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

  Between Day 1 pre-dose and Day 4

Study Arms (4)

GLPG3667 SD

EXPERIMENTAL

Participants will receive a single dose of GLPG3667

Drug: GLPG3667

Placebo SD

PLACEBO COMPARATOR

Participants will receive a single dose of matching placebo

Drug: Placebo

GLPG3667 MD

EXPERIMENTAL

Participants will receive repeated doses of GLPG3667 for 13 days.

Drug: GLPG3667

Placebo MD

PLACEBO COMPARATOR

Participants will receive repeated doses of matching placebo for 13 days.

Drug: Placebo

Interventions

GLPG3667 DRUG

GLPG3667 capsules

GLPG3667 MD; GLPG3667 SD

Placebo DRUG

Matching placebo capsules

Placebo MD; Placebo SD

Eligibility Criteria

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

You may qualify if:

• Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).
• A body mass index (BMI) between 18.0 and 30.0 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. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be below the upper limit of normal. 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 product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
• 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 has resolved at least 3 months prior to first dosing of the IP.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Drug Research Unit Ghent

Ghent, 9000, Belgium

Location

Study Officials

• Natalia Rueda-Rincon, MD, PhD

  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: July 19, 2021
• First Posted: July 26, 2021
• Study Start: July 20, 2021
• Primary Completion: January 14, 2022
• Study Completion: January 14, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)