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

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG3970 oral solution; Drug: GLPG3970 tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04708184

2020-003997-34 (EudraCT Number)

GLPG3970-CL-104

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

GLPG3970 solution

Experimental group

Description:

Single oral dose of GLPG3970 in fasted conditions

Treatment:

Drug: GLPG3970 oral solution

GLPG3970 tablet fasted

Experimental group

Description:

Single oral dose of GLPG3970 in fasted conditions

Treatment:

Drug: GLPG3970 tablet

GLPG3970 tablet fed

Experimental group

Description:

Single oral dose of GLPG3970 in fed conditions

Treatment:

Drug: GLPG3970 tablet