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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG3970 oral solution; Drug: GLPG3970 tablet

• Registration Number: NCT04708184
• Lead Sponsor: Galapagos NV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-07
• Study Start: 2021-01-11
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-13
• Primary Completion: 2021-02-25
• Study Completion: 2021-02-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GLPG3970 solution	GLPG3970 oral solution	Single oral dose of GLPG3970 in fasted conditions
GLPG3970 tablet fasted	GLPG3970 tablet	Single oral dose of GLPG3970 in fasted conditions
GLPG3970 tablet fed	GLPG3970 tablet	Single oral dose of GLPG3970 in fed conditions

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Biotral Rennes; 🇫🇷 Rennes, France