A PHASE 1, OPEN LABEL, SINGLE DOSE, 4TREATMENT, PARALLEL GROUP STUDY TO EVALUATE THE EFFECT OF DIFFERENT MEAL REGIMENS AND THE EFFECT OF PROLONGED GASTRIC ACID SUPPRESSION BY RABEPRAZOLE ON THE RELATIVE ORAL BIOAVAILABILITY OF DERAZANTINIB IN HEALTHY MALE SUBJECTS
- Conditions
- Healthy subjects10017991
- Registration Number
- NL-OMON48122
- Lead Sponsor
- Basilea Pharmaceutica International Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 48
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Plasma derazantinib and rabeprazole concentrations<br /><br><br /><br>Plasma derazantinib pharmacokinetic (PK) parameters estimated using<br /><br>noncompartmental analysis, as appropriate: Cmax, tmax, tlag, AUC0-t, AUC0-inf,<br /><br>%AUCextra, kel, t1/2, CL/F, Vss/F and Vz/F</p><br>
- Secondary Outcome Measures
Name Time Method <p>Adverse events, clinical laboratory, vital signs, 12-lead electrocardiogram,<br /><br>and physical examination</p><br>