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

NCT ID: NCT04137341

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-09
• Study Completion Date: 2019-12-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Tablet A

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

Group Type: EXPERIMENTAL

GLPG1972 - A

Intervention Type: DRUG

Film-coated tablet, formulation A

Tablet B

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

Group Type: EXPERIMENTAL

GLPG1972 - B

Intervention Type: DRUG

Film-coated tablet, formulation B

Tablet C

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

Group Type: EXPERIMENTAL

GLPG1972 - C

Intervention Type: DRUG

Film-coated tablet, formulation C

Food effect

selected tablet B or C under fed conditions

Group Type: EXPERIMENTAL

GLPG1972 - B

Intervention Type: DRUG

Film-coated tablet, formulation B

GLPG1972 - C

Intervention Type: DRUG

Film-coated tablet, formulation C

Interventions

GLPG1972 - A

Film-coated tablet, formulation A

Intervention Type: DRUG

GLPG1972 - B

Film-coated tablet, formulation B

Intervention Type: DRUG

GLPG1972 - C

Film-coated tablet, formulation C

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela de Haas-Amatsaleh, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

Quotient Sciences Limited

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2019-002144-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG1972-CL-109

Identifier Type: -

Identifier Source: org_study_id