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

Galapagos NV32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

GLPG1205DRUG

GLPG1205 film-coated tablets

PlaceboDRUG

placebo film-coated tablets

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

WCCT Global

Cypress, California, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

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

Data from ClinicalTrials.gov

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