Healthy ParticipantsPhase 1NCT04916769

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

A Phase 1 study testing Bosutinib capsule in people with Healthy Participants, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Bosutinib capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteBelgium
Study dates: 13 Aug 2021to 27 Jan 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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:
estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) < 90 mL/min/1.73 m2;
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > upper limit of normal (ULN);
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;
Amylase and lipase levels > ULN.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

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

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.

Conditions: Healthy Participants
Being tested: Bosutinib capsule
Keywords: Bioavailability, bosutinib, Maximum Observed Plasma Concentration (Cmax), Area Under the Curve (AUC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bosutinib capsuleDrug
500 mg dose of bosutinib capsule contents mixed with applesauce
Bosutinib capsuleDrug
500 mg dose of bosutinib capsule contents mixed with yogurt
Bosutinib capsuleDrug
500 mg dose of intact bosutinib capsules

Study groups in NCT04916769
Study group	Role	What they receive
Bosutinib capsule contents mixed with applesauce	Experimental	Bosutinib capsule contents mixed with applesauce to healthy participants Receives: Drug: Bosutinib capsule
Bosutinib capsule contents mixed with yogurt	Experimental	Bosutinib capsule contents mixed with yogurt to healthy participants Receives: Drug: Bosutinib capsule
Bosutinib intact capsules	Active comparator	Bosutinib intact capsules to healthy participants Receives: Drug: Bosutinib capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Bosutinib
AUCinf was calculated as [AUClast+(Clast*/kel)], where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the Clast, Clast is the last quantifiable concentration, Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The geometric coefficient of variation was reported as percentage.
Measured: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Maximum Observed Plasma Concentration (Cmax) for Bosutinib
Cmax was the maximum observed plasma concentration. The geometric coefficient of variation was reported as percentage.
Measured: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose

Secondary outcomes (7)

Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Bosutinib
AUClast was the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration. Linear/Log trapezoidal method was used to determine AUClast. The geometric coefficient of variation was reported as percentage.
Measured: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Bosutinib
Tmax was the time to reach maximum observed plasma concentration and was observed directly from data as time of the first occurrence.
Measured: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Apparent Clearance After Oral Dose (CL/F) for Bosutinib
CL/F was the apparent clearance after oral dose and was determined as dose/AUCinf. The geometric coefficient of variation was reported as percentage.
Measured: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Apparent Volume of Distribution After Oral Dose (Vz/F) for Bosutinib
Vz/F was the apparent volume of distribution after oral dose. It was determined as dose/(AUCinf × kel), where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration time curve. The geometric coefficient of variation was reported as percentage.
Measured: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Terminal Phase Half-life (t½ ) for Bosutinib
t½ was the terminal elimination plasma half-life. It was determined as Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Number of Participants With Laboratory Abnormalities
Laboratory tests included hematology tests, chemistry tests, and urinalysis tests.
Measured: Post first dose and up to Day 7 in Period 3, or at early termination/discontinuation.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Severe Adverse Events (AEs), and Serious Adverse Events (SAEs)
TEAEs are those with initial onset or that worsen in severity after the first dose of the study medication. All AEs in the table below were TEAEs. An SAE is any untoward medical occurrence at any dose that: results in death; is life threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect; or that is considered to be an important medical event. Severe AEs were defined as AEs that interfered significantly with participant's usual function. Both SAEs and severe AEs were according to the investigator's assessment.
Measured: Up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 202127 Jan 2022

First posted8 Jun 2021
Study start13 Aug 2021
Primary completion27 Jan 2022
Study completion27 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: A Phase 1, open-label, randomized, single dose, 3-period, 6-sequence, crossover study in healthy participants
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04916769
Sponsor's protocol ID: B1871063
Other IDs: 2021-000500-38
Status last verified: Nov 2024
First submitted: 1 Jun 2021
Last updated: 7 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04916769
Acronym / sponsor ID: B1871063
Conditions: Healthy Participants
Keywords: Bioavailability, bosutinib, Maximum Observed Plasma Concentration (Cmax), Area Under the Curve (AUC)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 13 Aug 2021 (actual)
Primary completion: 27 Jan 2022 (actual)
Study completion: 27 Jan 2022 (actual)
First posted: 8 Jun 2021 (actual)
Results: Posted 7 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: A Phase 1, open-label, randomized, single dose, 3-period, 6-sequence, crossover study in healthy participants

Arm	Type	Receives
Bosutinib capsule contents mixed with applesauce	Experimental	Drug: Bosutinib capsuleBosutinib capsule contents mixed with applesauce to healthy participants
Bosutinib capsule contents mixed with yogurt	Experimental	Drug: Bosutinib capsuleBosutinib capsule contents mixed with yogurt to healthy participants
Bosutinib intact capsules	Active comparator	Drug: Bosutinib capsuleBosutinib intact capsules to healthy participants

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (7 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bosutinib capsule500 mg dose of bosutinib capsule contents mixed with applesauce	Drug	Bosutinib capsule contents mixed with applesauce
Bosutinib capsule500 mg dose of bosutinib capsule contents mixed with yogurt	Drug	Bosutinib capsule contents mixed with yogurt
Bosutinib capsule500 mg dose of intact bosutinib capsules	Drug	Bosutinib intact capsules

Primary outcome

Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Bosutinib
Time frame: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
AUCinf was calculated as [AUClast+(Clast*/kel)], where AUClast is the area under the plasma concentration-time profile from time 0 to the time of the Clast, Clast is the last quantifiable concentration, Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. The geometric coefficient of variation was reported as percentage.
Maximum Observed Plasma Concentration (Cmax) for Bosutinib
Time frame: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Cmax was the maximum observed plasma concentration. The geometric coefficient of variation was reported as percentage.

7 secondary outcomes

Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for Bosutinib
Time frame: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Bosutinib
Time frame: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Apparent Clearance After Oral Dose (CL/F) for Bosutinib
Time frame: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Apparent Volume of Distribution After Oral Dose (Vz/F) for Bosutinib
Time frame: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Terminal Phase Half-life (t½ ) for Bosutinib
Time frame: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose
Number of Participants With Laboratory Abnormalities
Time frame: Post first dose and up to Day 7 in Period 3, or at early termination/discontinuation.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Severe Adverse Events (AEs), and Serious Adverse Events (SAEs)
Time frame: Up to 12 weeks

Results and safety

Results posted to the registry on 7 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: Treatment C=>Treatment A =>Treatment B	3	3
Sequence 2: Treatment B=>Treatment C =>Treatment A	3	3
Sequence 3: Treatment A=>Treatment B =>Treatment C	3	3
Sequence 4: Treatment B=>Treatment A =>Treatment C	3	3
Sequence 5: Treatment A=>Treatment C =>Treatment B	3	3
Sequence 6: Treatment C=>Treatment B =>Treatment A	3	2

Primary outcome: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Bosutinib

Time frame: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram•hour per milliliter (ng•hr/mL)

Measure	Bosutinib 500 mg Capsule Contents + Applesauce 45 mL n = 16	Bosutinib 500 mg Capsule Contents + Yogurt 45 mL n = 17	Bosutinib 500 mg Intact Capsule n = 17
Value	3312 (28)	3205 (23)	3161 (32)

Bosutinib 500 mg Capsule Contents + Applesauce 45 mL vs Bosutinib 500 mg Intact Capsule: ratio of ajusted geometric means: 106.27 (90% CI 97.76 to 115.53)
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL vs Bosutinib 500 mg Intact Capsule: ratio of adjusted geometric means: 101.93 (90% CI 93.97 to 110.56)

Population analysed: Total number of participants received treatment and had bosutinib pharmacokinetic (PK) parameter contributing to the summary statistics.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) for Bosutinib

Measure	Bosutinib 500 mg Capsule Contents + Applesauce 45 mL n = 16	Bosutinib 500 mg Capsule Contents + Yogurt 45 mL n = 17	Bosutinib 500 mg Intact Capsule n = 17
Value	126.5 (31)	126.1 (27)	132.0 (33)

Bosutinib 500 mg Capsule Contents + Applesauce 45 mL vs Bosutinib 500 mg Intact Capsule: ratio of adjusted geometric means: 96.82 (90% CI 86.37 to 108.53)
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL vs Bosutinib 500 mg Intact Capsule: ratio of adjusted geometric means: 95.39 (90% CI 85.34 to 106.61)

Population analysed: Total number of participants received treatment and had bosutinib PK parameter contributing to the summary statistics.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bosutinib 500 mg Capsule Contents + Applesauce 45 mL	0 of 16 (0%)	11 of 16 (68.8%)	0 of 16
Bosutinib 500 mg Capsule Contents + Yogurt 45 mL	0 of 17 (0%)	14 of 17 (82.4%)	0 of 17
Bosutinib 500 mg Intact Capsule	0 of 18 (0%)	15 of 18 (83.3%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bosutinib capsule in people with Healthy Participants, run by Pfizer at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Bosutinib (time frame: Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04916769.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.