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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04708184

Enrollment

Registered

2021-01-13

Start date

2021-01-11

Completion date

2021-02-25

Last updated

2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGGLPG3970 oral solution

GLPG3970 for oral administration

DRUGGLPG3970 tablet

GLPG3970 for oral administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximum observed plasma concentration (Cmax) of GLPG3970	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.
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)	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.
Area under the plasma concentration-time curve from time zero until the last observed quantifiable concentration (AUC0-t)	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

Measure	Time frame	Description
Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity	From Day 1 through study completion, an average of 1 month	To evaluate the safety and tolerability of a single dose of GLPG3970.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026