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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG1205; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT Global

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: GLPG1205; GLPG1205 film-coated tablets
Placebo Comparator: 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.	Drug: Placebo; placebo film-coated tablets
Experimental: GLPG1205 dose B; Participants will receive 14 days q.d. dosing with dose B of GLPG1205 on Days 1 to 14.	Drug: GLPG1205; GLPG1205 film-coated tablets
Placebo Comparator: Placebo dose B; Participants will receive 14 days q.d. dosing placebo on Days 1 to 14.	Drug: Placebo; placebo film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Ekaterina Tankisheva, MD, PhD, Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Actual): December 10, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: GLPG1205-CL-121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No