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

Healthy Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04708184
• Other study ID #: GLPG3970-CL-104
• Secondary ID: 2020-003997-34
• Status: Completed
• Phase: Phase 1
• Start date: January 11, 2021
• Est. completion date: February 25, 2021

Study information

• Verified date: March 2021
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 25, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG3970 oral solution
GLPG3970 for oral administration
• GLPG3970 tablet
GLPG3970 for oral administration

Locations

Country	Name	City	State
France	Biotral Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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