Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04916769
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 3
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

This study is intended to estimate the relative bioavailability of a single 500 mg dose of bosutinib when administered as capsule contents mixed with applesauce or yogurt to intact capsules under fed condition in adult healthy participants. The comparisons will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. Statistical analyses will be performed comparing these parameters calculated after administration of a single 500 mg dose with the intact capsule formulation (100 mg x 5) as the Reference treatment and the capsule contents mixed with applesauce or yogurt (100 mg x 5) as the Test treatments.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: Bosutinib capsule; Drug: Bosutinib capsule; Drug: Bosutinib capsule	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: A Phase 1, open-label, randomized, single dose, 3-period, 6-sequence, crossover study in healthy participantsA Phase 1, open-label, randomized, single dose, 3-period, 6-sequence, crossover study in healthy participants
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A PHASE 1, OPEN-LABEL, RANDOMIZED, 3-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO EVALUATE THE BIOAVAILABILITY OF BOSUTINIB ADMINISTERED AS CAPSULE CONTENTS MIXED WITH APPLESAUCE OR YOGURT RELATIVE TO INTACT CAPSULES IN HEALTHY PARTICIPANTS UNDER FED CONDITION
• Actual Study Start Date: Aug 13, 2021
• Actual Primary Completion Date: Jan 27, 2022
• Actual Study Completion Date: Jan 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bosutinib capsule contents mixed with applesauce Bosutinib capsule contents mixed with applesauce to healthy participants	Drug: Bosutinib capsule; 500 mg dose of bosutinib capsule contents mixed with applesauce
Experimental: Bosutinib capsule contents mixed with yogurt Bosutinib capsule contents mixed with yogurt to healthy participants	Drug: Bosutinib capsule; 500 mg dose of bosutinib capsule contents mixed with yogurt
Active Comparator: Bosutinib intact capsules Bosutinib intact capsules to healthy participants	Drug: Bosutinib capsule; 500 mg dose of intact bosutinib capsules

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] [6 days]

2. Cmax [6 days]

Secondary Outcome Measures

1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [6 days]

2. Time to Cmax (Tmax) [6 days]

3. Apparent Oral Clearance (CL/F) [6 days]

4. Apparent Volume of Distribution (Vz/F) [6 days]

5. Plasma elimination half-life (t1/2) [6 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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 informed consent document (ICD).

• 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:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease.

• Any condition possibly affecting drug absorption.

• Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:

1. estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) < 90 mL/min/1.73 m2;

2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > upper limit of normal (ULN);

3. Serum (total and direct) bilirubin level > ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN;

4. Amylase and lipase levels > ULN.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brussels Clinical Research Unit	Brussels	Bruxelles-capitale, Région DE	Belgium	B-1070

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04916769
• Other Study ID Numbers: B1871063; 2021-000500-38
• First Posted: Jun 8, 2021
• Last Update Posted: Feb 11, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: Bioavailability; bosutinib; Maximum Observed Plasma Concentration (Cmax); Area Under the Curve (AUC)
• Additional relevant MeSH terms: Malnutrition

Study Results

No Results Posted as of Feb 11, 2022