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

NCT ID: NCT04708184

Last Updated: 2021-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2021-02-25

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLPG3970 solution

Single oral dose of GLPG3970 in fasted conditions

Group Type: EXPERIMENTAL

GLPG3970 oral solution

Intervention Type: DRUG

GLPG3970 for oral administration

GLPG3970 tablet fasted

Single oral dose of GLPG3970 in fasted conditions

Group Type: EXPERIMENTAL

GLPG3970 tablet

Intervention Type: DRUG

GLPG3970 for oral administration

GLPG3970 tablet fed

Single oral dose of GLPG3970 in fed conditions

Group Type: EXPERIMENTAL

GLPG3970 tablet

Intervention Type: DRUG

GLPG3970 for oral administration

Interventions

GLPG3970 oral solution

GLPG3970 for oral administration

Intervention Type: DRUG

GLPG3970 tablet

GLPG3970 for oral administration

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ekaterina Tankisheva, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Biotral Rennes

Rennes, , France

Countries

France

Other Identifiers

2020-003997-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG3970-CL-104

Identifier Type: -

Identifier Source: org_study_id