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Completed

NCT Number: NCT04708184

A Study to Assess Relative Bioavailability of and Effect of Food on a New Oral Tablet Formulation of GLPG3970

This is a study to assess the relative bioavailability of a GLPG3970 oral tablet formulation compared to an oral solution formulation and the effect of food on the bioavailability of a single dose of the oral tablet formulation of GLPG3970. It will also evaluate the safety and tolerability of a single dose of GLPG3970.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Biotral Rennes

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female subject between 18 and 55 years of age (extremes included), on the date of signing the informed consent form .
  • A body mass index 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. Total bilirubin, aspartate aminotransferase, and alanine aminotransferase must be no greater than 1.5x upper limit of normal range. 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.

This list only contains the key exclusion criterion.

Treatment and study plan

GLPG3970 oral solution

Drug

GLPG3970 for oral administration

GLPG3970 tablet

Drug

GLPG3970 for oral administration

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of GLPG3970

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

    To assess the bioavailability (BA) of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970.

  2. Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)

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

    To assess the BA of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970.

  3. Area under the plasma concentration-time curve from time zero until the last observed quantifiable concentration (AUC0-t)

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

    To assess the BA of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970.

Secondary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity

    Time frame: From Day 1 through study completion, an average of 1 month

    To evaluate the safety and tolerability of a single dose of GLPG3970.

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

A Randomized, Open-label, 3-period, Single-dose, Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of GLPG3970 Given as an Oral Tablet Formulation Versus the Oral Solution Formulation of GLPG3970 and to Assess the Effect of Food on the Oral Tablet Formulation.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2021
Registry last updated
Mar 25, 2021

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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