The purpose of this study is to investigate how quickly and to what extent bosutinib is absorbed and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of bosutinib administered as a capsule will be compared to the…
ID
Source
Brief title
Condition
- Leukaemias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Bosutinib is a compound that is used for the treatment of chronic myeloid
leukemia (CML). The tablet formulation of bosutinib is already approved for the
treatment of CML in the Europe (EU) and the USA. The Sponsor is developing a
capsule formulation, which is more appropriate for the treatment of certain
types of patients (eg, children).
Study objective
The purpose of this study is to investigate how quickly and to what extent
bosutinib is absorbed and eliminated from the body (this is called
pharmacokinetics). The pharmacokinetics of bosutinib administered as a capsule
will be compared to the pharmacokinetics of bosutinib administered as a tablet.
Study design
The volunteer will receive bosutinib once as an oral tablet and once as an oral
capsule. Bosutinib will be ingested with approximately 240 milliliters (mL) of
(tap) water. In both administrations, the dose will be 100 mg.
The actual study will consist of 2 periods. During each period, the volunteer
will stay in the research center for 6 days (5 nights).
Intervention
N/A
Study burden and risks
The following side effects have been observed in people taking bosutinib:
Very frequently observed (in more than 1 in 10 people):
• Abdominal pain
• Appetite decrease
• Back pain
• Common cold (nasopharyngitis)
• Diarrhea
• Difficulty breathing (dyspnea)
• Dizziness
• Fatigue
• Fever (pyrexia)
• Headache (cephalgia)
• Joint pain (arthralgia)
• Lipase elevation (a pancreatic enzyme)
• Liver enzyme increase (ALT, AST)
• Loss of strength (asthenia)
• Nausea
• Platelet decrease (thrombocytopenia)
• Rash
• Red blood cell decrease (anemia)
• Respiratory tract infection (including upper lower, and viral respiratory
tract infections)
• Swelling (oedema) including face, arms, legs, and localized swelling
• Vomiting
• White blood cell (neutrophil) decrease (neutropenia)
East 42nd Street 235
New York NY 10017
US
East 42nd Street 235
New York NY 10017
US
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2020-002782-34-NL |
| CCMO | NL74763.056.20 |