A Study in Healthy Volunteers to Compare Different Tablet Formulations of the Test Medicine, GLPG1972, Against the Current Tablet Formulation, and to Assess the Effect Food Has on One of the Test Medicines

A Randomized, Open-label, Four-period, Single-dose Cross-over Study in Healthy Male Subjects to Assess the Relative Bioavailability of Two Candidate Tablet Formulations Versus the Current Tablet Formulation of GLPG1972 and to Assess the Food Effect of the Tablet Formulation Selected for Phase 3 in Period 4

The sponsor wants to investigate two new tablet formulations (recipes) of the test medicine, and how they are taken up by the body in comparison to the current tablet formulation (study periods 1 to 3). If one of the 2 new tablets has a more favourable profile than the current tablet in periods 1 to 3, the sponsor will then investigate the effect that food has on this new tablet in study period 4. However, if the new tablets do not have a more favourable profile than the current tablet, the food effect does not need to be investigated and study period 4 will not be needed.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG1972 - A; Drug: GLPG1972 - B; Drug: GLPG1972 - C

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Sciences Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male between 18-55 years of age (extremes included), on the date of signing the informed consent form
• A body mass index (BMI) between 18.0-30.0 kg/m2, inclusive
• Judged to be in good health by the investigator based upon the results of medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator
• Subject must be able and willing to comply with restrictions on prior medication as described in the protocol
• Negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol

Exclusion Criteria:

• Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to the investigational medicinal product (IMP) ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hay fever is allowed unless active.
• Positive serology for hepatitis B virus surface antigen or hepatitis C virus or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first IMP administration.
• History of or a current immunosuppressive condition (e.g. human immunodeficiency virus infection)
• Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first IMP administration.
• Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min, using the Cockcroft-Gault formula: if calculated result is ≤80 mL/min, a 24-hour urine collection can be done) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tablet A; A single oral 300-mg dose of GLPG1972 in fasted state	Drug: GLPG1972 - A; Film-coated tablet, formulation A
Experimental: Tablet B; A single oral 300-mg dose of GLPG1972 in fasted state	Drug: GLPG1972 - B; Film-coated tablet, formulation B
Experimental: Tablet C; A single oral 300-mg dose of GLPG1972 in fasted state	Drug: GLPG1972 - C; Film-coated tablet, formulation C
Experimental: Food effect; selected tablet B or C under fed conditions	Drug: GLPG1972 - B; Film-coated tablet, formulation B; Drug: GLPG1972 - C; Film-coated tablet, formulation C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration-time curve from time zero until the time corresponding with the last observed quantifiable concentration calculated by the linear up (AUC0-t) ratio between tablet formulations	To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972	From Day 1 pre-dose up to Day 4
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) ratio between tablet formulations	To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972	From Day 1 pre-dose up to Day 4
Maximum observed plasma concentration (Cmax) ratio between tablet formulations	To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972	From Day 1 pre-dose up to Day 4
Area under the plasma concentration-time curve from time zero until the time corresponding with the last observed quantifiable concentration calculated by the linear up (AUC0-t) ratio between fed and fasted	To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972	From Day 1 pre-dose up to Day 4
Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) ratio between fed and fasted	To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972	From Day 1 pre-dose up to Day 4
Maximum observed plasma concentration (Cmax) ratio between fed and fasted	To assess the bioavailability of two candidate tablet formulations (Tablet B and Tablet C) relative to that of the current tablet formulation (Tablet A) of GLPG1972	From Day 1 pre-dose up to Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations	To evaluate the safety and tolerability of oral doses of GLPG1972 tablet formulations	From Day 1 through study completion, an average of 2 months

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Angela de Haas-Amatsaleh, MD, Galapagos NV

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2019
• Primary Completion (Actual): December 13, 2019
• Study Completion (Actual): December 13, 2019

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: GLPG1972-CL-109; 2019-002144-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No