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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532567
• Other study ID #: GLPG1205-CL-121
• Status: Completed
• Phase: Phase 1
• Start date: August 18, 2020
• Est. completion date: December 10, 2020

Study information

• Verified date: December 2020
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG1205
GLPG1205 film-coated tablets
• Placebo
placebo film-coated tablets

Locations

Country	Name	City	State
United States	WCCT Global	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From screening through study completion, an average of 3 months
Primary	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	Between Day 1 pre-dose and Day 18 and at follow-up Day 32
Primary	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	Between Day 1 pre-dose and Day 18 and at follow-up Day 32
Primary	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	Between Day 1 pre-dose and Day 18 and at follow-up Day 32