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

NCT04137341 | Completed Phase 1

• 2 other identifiers: GLPG1972-CL-1092019-002144-25
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations

  From Day 1 through study completion, an average of 2 months

Study Arms (4)

Tablet A

EXPERIMENTAL

A single oral 300-mg dose of GLPG1972 in fasted state

Drug: GLPG1972 - A

Tablet B

EXPERIMENTAL

A single oral 300-mg dose of GLPG1972 in fasted state

Drug: GLPG1972 - B

Tablet C

EXPERIMENTAL

A single oral 300-mg dose of GLPG1972 in fasted state

Drug: GLPG1972 - C

Food effect

EXPERIMENTAL

selected tablet B or C under fed conditions

Drug: GLPG1972 - B; Drug: GLPG1972 - C

Interventions

GLPG1972 - A DRUG

Film-coated tablet, formulation A

Tablet A

GLPG1972 - B DRUG

Film-coated tablet, formulation B

Food effect; Tablet B

GLPG1972 - C DRUG

Film-coated tablet, formulation C

Food effect; Tablet C

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Quotient Sciences Limited

Nottingham, NG11 6JS, United Kingdom

Location

Study Officials

• Angela de Haas-Amatsaleh, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: October 9, 2019
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)