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

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG1972 - A; Drug: GLPG1972 - C; Drug: GLPG1972 - B

Study type: Interventional

Funder types: Industry

Identifiers

NCT04137341

2019-002144-25 (EudraCT Number)

GLPG1972-CL-109

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

Tablet A

Experimental group

Description:

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

Treatment:

Drug: GLPG1972 - A

Tablet B

Experimental group

Description:

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

Treatment:

Drug: GLPG1972 - B

Tablet C

Experimental group

Description:

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

Treatment:

Drug: GLPG1972 - C

Food effect

Experimental group

Description:

selected tablet B or C under fed conditions

Treatment:

Drug: GLPG1972 - C

Drug: GLPG1972 - B