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

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2021

Interventions

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

Arms, Groups and Cohorts

  • Experimental: GLPG3970 solution
    • Single oral dose of GLPG3970 in fasted conditions
  • Experimental: GLPG3970 tablet fasted
    • Single oral dose of GLPG3970 in fasted conditions
  • Experimental: GLPG3970 tablet fed
    • Single oral dose of GLPG3970 in fed conditions

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Galapagos NV
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ekaterina Tankisheva, MD, Study Director, Galapagos NV
  • Overall Contact(s)
    • Galapagos Medical Information, +3215342900, medicalinfo@glpg.com

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