Healthy
Conditions
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.
Interventions
DRUGGLPG1972 - A
Film-coated tablet, formulation A
DRUGGLPG1972 - B
Film-coated tablet, formulation B
DRUGGLPG1972 - C
Film-coated tablet, formulation C
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From Day 1 pre-dose up to Day 4 | 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 |
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) ratio between tablet formulations | From Day 1 pre-dose up to Day 4 | 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 |
| Maximum observed plasma concentration (Cmax) ratio between tablet formulations | From Day 1 pre-dose up to Day 4 | To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972 |
| 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 | From Day 1 pre-dose up to Day 4 | To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972 |
| Area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) ratio between fed and fasted | From Day 1 pre-dose up to Day 4 | To assess the food effect of the selected Phase 3 tablet formulation (in case Tablet B or Tablet C) of GLPG1972 |
| Maximum observed plasma concentration (Cmax) ratio between fed and fasted | From Day 1 pre-dose up to Day 4 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | To evaluate the safety and tolerability of oral doses of GLPG1972 tablet formulations |
Countries
United Kingdom
Outcome results
None listed