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

NCT04708184 | Completed Phase 1

• 2 other identifiers: GLPG3970-CL-1042020-003997-34
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity

  From Day 1 through study completion, an average of 1 month

Study Arms (3)

GLPG3970 solution

EXPERIMENTAL

Single oral dose of GLPG3970 in fasted conditions

Drug: GLPG3970 oral solution

GLPG3970 tablet fasted

EXPERIMENTAL

Single oral dose of GLPG3970 in fasted conditions

Drug: GLPG3970 tablet

GLPG3970 tablet fed

EXPERIMENTAL

Single oral dose of GLPG3970 in fed conditions

Drug: GLPG3970 tablet

Interventions

GLPG3970 oral solution DRUG

GLPG3970 for oral administration

GLPG3970 solution

GLPG3970 tablet DRUG

GLPG3970 for oral administration

GLPG3970 tablet fasted; GLPG3970 tablet fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Biotral Rennes

Rennes, 35042, France

Location

Study Officials

• Ekaterina Tankisheva, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 13, 2021
• Study Start: January 11, 2021
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)