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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG3970 oral solution; Drug: GLPG3970 tablet

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35042
    • Biotral Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GLPG3970 solution; Single oral dose of GLPG3970 in fasted conditions	Drug: GLPG3970 oral solution; GLPG3970 for oral administration
EXPERIMENTAL: GLPG3970 tablet fasted; Single oral dose of GLPG3970 in fasted conditions	Drug: GLPG3970 tablet; GLPG3970 for oral administration
EXPERIMENTAL: GLPG3970 tablet fed; Single oral dose of GLPG3970 in fed conditions	Drug: GLPG3970 tablet; GLPG3970 for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) of GLPG3970	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.	Between Day 1 pre-dose and Day 4
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)	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.	Between Day 1 pre-dose and Day 4
Area under the plasma concentration-time curve from time zero until the last observed quantifiable concentration (AUC0-t)	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.	Between Day 1 pre-dose and Day 4

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Galapagos NV

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 11, 2021
• Primary Completion (ACTUAL): February 25, 2021
• Study Completion (ACTUAL): February 25, 2021

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (ACTUAL): January 13, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: GLPG3970-CL-104; 2020-003997-34 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No