A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Healthy Japanese and Caucasian Male Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT04532567
- Run by
- Lakefront Biotherapeutics NV
- People needed
- 32
- Starts
- 2020-08-18
- Expected to finish
- 2020-12-10
- Last updated by the study team
- 2020-12-22
Who can join
Age: 20 and older, up to 55. Sex: male. Healthy volunteers: accepted.
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.
Where it is running
- WCCT Global — Cypress, California, United States
Full record on ClinicalTrials.gov
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