Healthy subjects
Conditions
Interventions
Group 1, 2, 3:
A dose of 300 mg derazantinib will be administered in the morning of Day 1 as 3
oral capsules together with 240 mL of tap water.
Group 4:
On Days 1 to 5, a dose of 20 mg rabeprazole w
Sponsors
Basilea Pharmaceutica International Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Able to communicate well with the Investigator, and able to understand and comply with the requirements of the study. He should also be able to understand and sign the ICF. 2. Has signed the ICF prior to initiation of any studyspecific procedures. 3. Male subjects between 18 and 55 years of age, inclusive, having a body mass index within the range of 18.0 kg/m2 to 29.0 kg/m2, inclusive, and weighing at least 50 kg at screening. 4. In good health as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests (clinical chemistry, hematology, and urinalysis) at screening. 5. Supine vital signs within the following ranges at screening: • Systolic blood pressure: 90 mmHg to 140 mmHg, inclusive • Diastolic blood pressure: 50 mmHg to 90 mmHg, inclusive • Pulse rate: 40 bpm to 90 bpm, inclusive • Body temperature: 35.5°C to 37.6°C, inclusive When measuring standing vital signs, there should be no more than a 20 mmHg decrease in systolic blood pressure or 10 mmHg decrease in diastolic blood pressure as this is an indication of postural hypotension. Any subject exhibiting clinical manifestations of postural hypotension should be excluded.
Exclusion criteria
Exclusion criteria: 1. Previous participation in the current study. 2. Employee of PRA or the Sponsor. 3. Legal incapacity or limited legal capacity at screening. 4. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes, or history of relevant drug and/or food allergies. 5. Known hypersensitivity or allergy to natural rubber latex.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma derazantinib and rabeprazole concentrations Plasma derazantinib pharmacokinetic (PK) parameters estimated using noncompartmental analysis, as appropriate: Cmax, tmax, tlag, AUC0-t, AUC0-inf, %AUCextra, kel, t1/2, CL/F, Vss/F and Vz/F | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination | — |
Countries
Netherlands
Outcome results
None listed