A phase 1, open-label, randomized, 2-period, 2-sequence, crossover study to evaluate the bioequivalence of Bosutinib pediatric capsule and the commercial tablet formulations in healthy participants under fed conditio
- Conditions
- chronic myeloid leukemia10024324
- Registration Number
- NL-OMON49458
- Lead Sponsor
- Pfizer, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
1. Female participants of non-childbearing potential and/or male participants
must be 18 to 54 years of age, inclusive, at the time of signing the ICD.
2. Male and female participants who are overtly healthy as determined by
medical evaluation including a detailed medical history, complete physical
examination, vital signs which include BP and pulse rate measurement, clinical
laboratory tests, and ECG.
3. Participants who are willing and able to comply with all scheduled visits,
treatment plan, laboratory tests, lifestyle considerations, and other study
procedures.
4. BMI of 17.5 to 30.0 kg/m2; and a total body weight >50 kg (110 lb).
5. Capable of giving signed informed consent as described in Appendix 1, which
includes compliance with the requirements and restrictions listed in the ICD
and in this protocol.
1. Evidence or history of clinically significant hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurological, dermatological, or allergic disease (including drug allergies,
but excluding untreated, asymptomatic, seasonal allergies at the time of
dosing).
2. Any condition possibly affecting drug absorption (eg, gastrectomy,
cholecystectomy).
3. History of HIV infection, hepatitis B, or hepatitis C; positive testing for
HIV, HBsAg, HBcAb or HCVAb. As an exception, a positive HBsAb as a result of
participant vaccination is permissible.
4. Other medical or psychiatric condition including recent (within the past
year) or active suicidal ideation/behavior or laboratory abnormality that may
increase the risk
PF-05208763 of study participation or, in the investigator*s judgment, make the
participant inappropriate for the study.
5. A history of hypersensitivity to the active compounds or to any inactive
ingredients (excipients) contained in the formulations.
For complete overview see the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the bioequivalence of bosutinib pediatric capsule formulation (Test)<br /><br>to the commercial tablet formulation (Reference) at a 100 mg dose under fed<br /><br>condition in adult healthy participants.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the PK of bosutinib when administered as a capsule and tablet<br /><br>formulation to healthy participants under fed condition.<br /><br>To evaluate the safety and tolerability of bosutinib when administered as a<br /><br>capsule and tablet formulation to healthy participants under fed condition.</p><br>