chronic myeloid leukemia
Conditions
Interventions
None listed
Sponsors
Pfizer, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence of bosutinib pediatric capsule formulation (Test) to the commercial tablet formulation (Reference) at a 100 mg dose under fed condition in adult healthy participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the PK of bosutinib when administered as a capsule and tablet formulation to healthy participants under fed condition. To evaluate the safety and tolerability of bosutinib when administered as a capsule and tablet formulation to healthy participants under fed condition. | — |
Countries
Netherlands
Outcome results
None listed