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

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG1205; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04532567

GLPG1205-CL-121

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups, including a placebo group

GLPG1205 dose A

Experimental group

Description:

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.

Treatment:

Drug: GLPG1205

Placebo dose A

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

GLPG1205 dose B

Experimental group

Description:

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

Treatment:

Drug: GLPG1205

Placebo dose B

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo