A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Healthy Japanese and Caucasian Male Subjects

NCT04532567 | Completed Phase 1 FDA Drug

• 1 other identifier: GLPG1205-CL-121
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to assess the safety and tolerability of GLPG1205 in single and multiple oral doses in healthy male Caucasian and Japanese subjects. This study will also assess the pharmacokinetics (PK) across different doses of GLPG1205. PK will look at how the study drug is absorbed, broken down, and eliminated by your body.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation

  To evaluate the safety and tolerability of single and multiple oral doses of GLPG1205 in healthy male Japanese and Caucasian subjects

  From screening through study completion, an average of 3 months

• Maximum observed plasma concentration (Cmax) of GLPG1205

  To assess the PK of single and multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects

  Between Day 1 pre-dose and Day 18 and at follow-up Day 32

• Area under the plasma concentration-time curve from time zero till 24 hours postdose (AUC 0-24h) of GLPG1205

  To assess the PK of single oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects

  Between Day 1 pre-dose and Day 18 and at follow-up Day 32

• Area under the plasma concentration-time curve over the dosing interval (AUC T) of GLPG1205

  To assess the PK of multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects

  Between Day 1 pre-dose and Day 18 and at follow-up Day 32

Study Arms (4)

GLPG1205 dose A

EXPERIMENTAL

Participants will receive a single dose with dose A of GLPG1205 on Day 1 in Period 1, and 14 days q.d. dosing on Days 1 to 14 in Period 2.

Drug: GLPG1205

Placebo dose A

PLACEBO COMPARATOR

Participants will receive a single dose placebo on Day 1 in Period 1, and 14 days q.d. dosing on Days 1 to 14 in Period 2.

Drug: Placebo

GLPG1205 dose B

EXPERIMENTAL

Participants will receive 14 days q.d. dosing with dose B of GLPG1205 on Days 1 to 14.

Drug: GLPG1205

Placebo dose B

PLACEBO COMPARATOR

Participants will receive 14 days q.d. dosing placebo on Days 1 to 14.

Drug: Placebo

Interventions

GLPG1205 DRUG

GLPG1205 film-coated tablets

GLPG1205 dose A; GLPG1205 dose B

Placebo DRUG

placebo film-coated tablets

Placebo dose A; Placebo dose B

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Caucasian and Japanese male between 20-55 years of age (extremes included), on the date of signing the informed consent form (ICF).
• Japanese subjects must be first generation Japanese of full Japanese parentage, and must have not lived outside Japan for more than 5 years. First generation subjects will have been born in Japan of 2 parents and 4 grandparents also born in Japan of full Japanese descent.
• A body mass index (BMI) between 18-26 kg/m2, extremes included, with a minimum body weight of 45 kg.
• Able and willing to comply with the protocol requirements and signing the ICF as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.

You may not qualify if:

• History of serious allergic reaction to any drug as determined by the investigator (e.g., anaphylaxis requiring hospitalization) and/or known sensitivity to the investigational product (IP) or its excipients as determined by the investigator.
• Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IP.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

WCCT Global

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

GLPG1205

Study Officials

• Ekaterina Tankisheva, 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 31, 2020
• Study Start: August 18, 2020
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)