Clinical trial NCT04532567: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Healthy Japanese and Caucasian Male Subjects
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of GLPG1205 for 14 Days in Healthy Japanese and Caucasian Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation
timeFrame: From screening through study completion, an average of 3 months
measure: Maximum observed plasma concentration (Cmax) of GLPG1205
timeFrame: Between Day 1 pre-dose and Day 18 and at follow-up Day 32
measure: Area under the plasma concentration-time curve from time zero till 24 hours postdose (AUC 0-24h) of GLPG1205
timeFrame: Between Day 1 pre-dose and Day 18 and at follow-up Day 32
measure: Area under the plasma concentration-time curve over the dosing interval (AUC T) of GLPG1205
timeFrame: Between Day 1 pre-dose and Day 18 and at follow-up Day 32
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global
state: California
Study officials:
affiliation: Galapagos NV
name: Ekaterina Tankisheva, MD, PhD
role: STUDY_DIRECTOR
References: