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NCT Number: NCT04532567

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GLPG1205 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.

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

WCCT Global

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GLPG1205

Drug

GLPG1205 film-coated tablets

Placebo

Drug

placebo film-coated tablets

Primary outcomes

  1. Frequency and severity of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation

    Time frame: From screening through study completion, an average of 3 months

    To evaluate the safety and tolerability of single and multiple oral doses of GLPG1205 in healthy male Japanese and Caucasian subjects

  2. Maximum observed plasma concentration (Cmax) of GLPG1205

    Time frame: Between Day 1 pre-dose and Day 18 and at follow-up Day 32

    To assess the PK of single and multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects

  3. Area under the plasma concentration-time curve from time zero till 24 hours postdose (AUC 0-24h) of GLPG1205

    Time frame: Between Day 1 pre-dose and Day 18 and at follow-up Day 32

    To assess the PK of single oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects

  4. Area under the plasma concentration-time curve over the dosing interval (AUC T) of GLPG1205

    Time frame: Between Day 1 pre-dose and Day 18 and at follow-up Day 32

    To assess the PK of multiple oral doses of GLPG1205 in healthy male Japanese subjects matched with healthy male Caucasian subjects

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 31, 2020
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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