Skip to main content
OpenTrials
Completed

NCT Number: NCT04097938

A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667

This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Belgium NV - Clinical Pharmacology Unit Antwerp

Antwerp, 2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male between 18-55 years of age (extremes included), on the date of signing the informed consent form (ICF)
  • A body mass index (BMI) between 18-30 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. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal ranges. 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

Exclusion criteria

  • Known hypersensitivity to Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator
  • Known contraindication or hypersensitivity to Interferon-alpha (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part)
  • 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 was resolved at least 3 months prior to first dosing of the IMP.

Treatment and study plan

GLPG3667 oral suspension

Drug

GLPG3667 oral suspension

Placebos

Drug

Placebo oral suspension

GLPG3667 capsules

Drug

GLPG3667 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 5 months

    To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) of GLPG3667 (μg/mL)

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

    To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects

  2. Area under curve (AUC) of GLPG3667 (μg.h/mL)

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

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

  3. Terminal elimination half-life (t1/2) of GLPG3667 (h)

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

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

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

A First-in-human Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3667 in Adult, Healthy, Male Subjects

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 20, 2019
Registry last updated
Sep 19, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.