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Completed

NCT Number: NCT04976270

A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects

This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667 (part 2) in healthy male subjects.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Drug Research Unit Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).
  • A body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
  • Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be below the upper limit of normal. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion criteria

  • Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
  • Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that has resolved at least 3 months prior to first dosing of the IP.

This list only contains the key exclusion criteria.

Treatment and study plan

GLPG3667

Drug

GLPG3667 capsules

Placebo

Drug

Matching placebo capsules

Primary outcomes

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

    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 GLPG3667, in adult, healthy, male subjects compared with placebo

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) of GLPG3667 - SD

    Time frame: Between Day 1 pre-dose and Day 4

    To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.

  2. Maximum observed plasma concentration (Cmax) of GLPG3667 - MD

    Time frame: Between Day 1 pre-dose and Day 16

    To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.

  3. Area under the plasma concentration-time curve (AUC) of GLPG3667 - SD

    Time frame: Between Day 1 pre-dose and Day 4

    To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.

  4. Area under the plasma concentration-time curve (AUC) of GLPG3667 - MD

    Time frame: Between Day 1 pre-dose and Day 16

    To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.

  5. Terminal elimination half-life (t1/2) of GLPG3667 - SD

    Time frame: Between Day 1 pre-dose and Day 4

    To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.

  6. Terminal elimination half-life (t1/2) of GLPG3667 - MD

    Time frame: Between Day 1 pre-dose and Day 16

    To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male 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 GLPG3667 in Adult, Healthy Male Subjects

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2021
Registry last updated
Feb 14, 2022

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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