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

NCT ID: NCT04532567

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-18

Study Completion Date

2020-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GLPG1205 dose A

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.

Group Type EXPERIMENTAL

GLPG1205

Intervention Type DRUG

GLPG1205 film-coated tablets

Placebo dose A

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo film-coated tablets

GLPG1205 dose B

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

Group Type EXPERIMENTAL

GLPG1205

Intervention Type DRUG

GLPG1205 film-coated tablets

Placebo dose B

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo film-coated tablets

Interventions

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GLPG1205

GLPG1205 film-coated tablets

Intervention Type DRUG

Placebo

placebo film-coated tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Galapagos NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ekaterina Tankisheva, MD, PhD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

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WCCT Global

Cypress, California, United States

Site Status

Countries

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United States

Other Identifiers

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GLPG1205-CL-121

Identifier Type: -

Identifier Source: org_study_id