Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004911-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is intended to estimate the bioavailability of a single 100 mg bosutinib capsules relative to four 25 mg capsules under fed condition in adult healthy participants and to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a single 100 mg capsule of bosutinib relative to fasted condition in adults healthy participants. The comparisons will be performed using the pharmacokinetic parameters that define the rate and extend of absorption (Cmax, AUC). Statistical analyses will be performed after the administration of a single 100 mg dose under fed condition as the Reference treatment and the four 25 mg capsules as the Test treatment for the first comparison, and after administration of a single 100 mg dose under fasted condition as the Reference treatment and the 100 mg capsule under fed condition as the Test treatment for the second comparison.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment B: Bosutinib four 25 mg capsule after meal | Experimental | Bosutinib four 25 mg capsule taken after a high-fat and high-calorie breakfast for comparison 1 |
|
| Treatment A: Bosutinib 100 mg capsule after meal (active comparator) | Active Comparator | Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast for comparison 1 |
|
| Treatment A: Bosutinib 100 mg capsule after meal (experimental) | Experimental | Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast for comparison 2 |
|
| Treatment C: Bosutinib 100 mg capsule after fasting | Active Comparator | Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours for comparison 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosutinib capsule | Drug | Bosutinib four 25 mg capsule taken after a high-fat and high calorie breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
Not provided
Inclusion Criteria:
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 (eg, gastrectomy, cholecystectomy).
History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg,hepatitis B surface antigen (HBcAb) or hepatitis C antibody (HCVAb).
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
A total of 32 participants were assigned to the study intervention, of whom 26 participants received all the randomized treatment by sequence and 25 participants completed the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A -> Treatment B -> Treatment C | Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. Treatment C: 1 × 100 mg bosutinib capsule under fasted condition. The participant took Treatment A in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment B in Period 2, followed with another at least 14-days washout between successive bosutinib doses, and then Treatment C in Period 3. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2021 | Jun 23, 2023 |
A Phase 1, open-label, randomized, single dose, 3-period, 4 sequence, crossover study in healthy participants
Not provided
Not provided
Not provided
Not provided
| Bosutinib capsule | Drug | Bosutinib 100 mg capsule taken after a high-fat and high calorie breakfast |
|
| Bosutinib | Drug | Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours |
|
| Bosutinib capsule | Drug | Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast |
|
| Time for Cmax (Tmax) of Bosutinib | Tmax was the time to reach maximum observed plasma concentration and was observed directly from data as time of the first occurrence. | 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) of 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. | 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) of 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. | 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 Elimination Half-Life (t1/2) of 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. | 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 (Without Regard to Baseline Abnormality) | Laboratory tests included hematology tests, chemistry tests, and urinalysis tests. Laboratory parameters with at least 1 occurrence meeting the pre-defined criteria are reported for this outcome measure. | On Days 4, 5, 7 of Periods 1 and 2 for all participants, on Period 3 Days 4, 5, 7 for participants who were assigned to treatment sequences A=>B=>C and B=>A=>C, and at early termination/discontinuation (if applicable) |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days) |
| FG001 | Treatment B -> Treatment A -> Treatment C | Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. Treatment C: 1 × 100 mg bosutinib capsule under fasted condition. The participant took Treatment B in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment A in Period 2, followed with another at least 14-days washout between successive bosutinib doses, and then Treatment C in Period 3. |
| FG002 | Treatment A ->Treatment B | Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition.The participant took Treatment A in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment B in Period 2. |
| FG003 | Treatment B->Treatment A | Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. The participant took Treatment B in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment A in Period 2. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 |
|
|
| Period 3 |
|
|
All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A -> Treatment B -> Treatment C | Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. Treatment C: 1 × 100 mg bosutinib capsule under fasted condition. The participant took Treatment A in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment B in Period 2, followed with another at least 14-days washout between successive bosutinib doses, and then Treatment C in Period 3. |
| BG001 | Treatment B -> Treatment A -> Treatment C | Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. Treatment C: 1 × 100 mg bosutinib capsule under fasted condition. The participant took Treatment B in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment A in Period 2, followed with another at least 14-days washout between successive bosutinib doses, and then Treatment C in Period 3. |
| BG002 | Treatment A ->Treatment B | Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition.The participant took Treatment A in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment B in Period 2. |
| BG003 | Treatment B->Treatment A | Treatment A: 1 × 100 mg bosutinib capsule under fed condition. Treatment B: 4 × 25 mg bosutinib capsules under fed condition. The participant took Treatment B in Period 1, followed with at least 14-days washout between successive bosutinib doses, and then Treatment A in Period 2. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The pharmacokinetic (PK) parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Predose (0 hour) and at 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 96, and 144 hours post bosutinib dose |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maximum Observed Plasma Concentration (Cmax) for Bosutinib | Cmax was the maximum observed plasma concentration. The geometric coefficient of variation was reported as percentage. | The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | 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 | 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. | The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | 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 | Time for Cmax (Tmax) of Bosutinib | Tmax was the time to reach maximum observed plasma concentration and was observed directly from data as time of the first occurrence. | The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Median | Full Range | hour | 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 | Apparent Clearance After Oral Dose (CL/F) of 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. | The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter/hour | 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 | Apparent Volume of Distribution After Oral Dose (Vz/F) of 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. | The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | liter | 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 | Terminal Elimination Half-Life (t1/2) of 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. | The PK parameter analysis population is defined as all subjects randomized and treated who have at least 1 of the PK parameters of primary interest in at least 1 treatment period. | Posted | Mean | Standard Deviation | hour | 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 | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Laboratory tests included hematology tests, chemistry tests, and urinalysis tests. Laboratory parameters with at least 1 occurrence meeting the pre-defined criteria are reported for this outcome measure. | All participants randomly assigned to study intervention and who take at least 1 dose of study intervention. | Posted | Count of Participants | Participants | On Days 4, 5, 7 of Periods 1 and 2 for all participants, on Period 3 Days 4, 5, 7 for participants who were assigned to treatment sequences A=>B=>C and B=>A=>C, and at early termination/discontinuation (if applicable) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days) |
|
Post first dose on Period 1 Day 1 up to 28 days post the last dose of study intervention (up to a maximum of 75 days)
Same event may appear as adverse event (AE) and serious AE, what is presented as distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all participants who were randomized and received at least 1 confirmed dose of investigational product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A: Bosutinib 1*100 mg Capsule Fed | Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast. | 0 | 30 | 0 | 30 | 13 | 30 |
| EG001 | Treatment B: Bosutinib 4*25 mg Capsule Fed | Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast. | 0 | 31 | 0 | 31 | 20 | 31 |
| EG002 | Treatment C: Bosutinib 1*100 mg Capsule Fasted | Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants received 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours). | 0 | 12 | 0 | 12 | 5 | 12 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear discomfort | Ear and labyrinth disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Change of bowel habit | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Electric shock | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v25.0 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Urine odour abnormal | Renal and urinary disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v25.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v25.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 8, 2021 | Jun 23, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| C471992 | bosutinib |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| No longer meets eligibility criteria |
|
| Male |
|
| Hispanic or Latino |
|
| For comparison of Bosutinib 1*100 mg Capsule Fed vs. Bosutinib 1*100 mg Capsule Fasted, the model is a mixed effect model with sequence and treatment as fixed effects and participant within sequence as a random effect. The reference treatment of Bosutinib 1*100 mg Capsule Fed is Bosutinib 1*100 mg Capsule Fasted. | Mixed Models Analysis | ratio of adjusted geometric means | 135.90 | 2-Sided | 90 | 109.28 | 169.01 | Equivalence | The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. The ratio of adjusted geometric means and 90% confidence interval were expressed as percentages. |
| OG002 | Treatment C: Bosutinib 1*100 mg Capsule Fasted | Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours). |
|
|
|
| OG002 | Treatment C: Bosutinib 1*100 mg Capsule Fasted | Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours). |
|
|
|
| OG002 | Treatment C: Bosutinib 1*100 mg Capsule Fasted | Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours). |
|
|
| OG002 | Treatment C: Bosutinib 1*100 mg Capsule Fasted | Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours). |
|
|
| OG002 | Treatment C: Bosutinib 1*100 mg Capsule Fasted | Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours). |
|
|
| OG002 | Treatment C: Bosutinib 1*100 mg Capsule Fasted | Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours). |
|
|
| OG002 | Treatment C: Bosutinib 1*100 mg Capsule Fasted | Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours). |
|
|
| OG001 |
| Treatment B: Bosutinib 4*25 mg Capsule Fed |
Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive a high-fat, high-calorie breakfast approximately 30 minutes prior to dosing which should be completed within approximately 20 minutes. The participants will then receive 4*25 mg capsule of bosutinib at approximately 0800 hours (±2 hours), approximately 10 minutes after the completion of the breakfast. |
| OG002 | Treatment C: Bosutinib 1*100 mg Capsule Fasted | Following an overnight fast of at least 10 hours and after the collection of predose bosutinib PK sample on Day 1, participants will receive 100 mg capsule of bosutinib at approximately 0800 hours (±2 hours). |
|
|