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Bosutinib capsule for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 days
Awards & highlights

Study Summary

This trial is comparing the absorption of a 100 mg bosutinib capsule to four 25 mg capsules, under both fed and fasted conditions, in healthy adults. The primary outcome measures are maximum concentration (Cmax) and area under the curve (AUC) of bosutinib.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)]
Cmax
Secondary outcome measures
Apparent Oral Clearance (CL/F)
Apparent Volume of Distribution (Vz/F)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
+2 more

Side effects data

From 2020 Phase 3 trial • 536 Patients • NCT02130557
75%
Diarrhoea
37%
Nausea
36%
Thrombocytopenia
34%
Alanine aminotransferase increased
26%
Aspartate aminotransferase increased
23%
Abdominal pain
23%
Rash
22%
Headache
22%
Anaemia
21%
Lipase increased
21%
Vomiting
21%
Fatigue
18%
Arthralgia
16%
Pyrexia
13%
Constipation
13%
Nasopharyngitis
13%
Asthenia
13%
Upper respiratory tract infection
12%
Back pain
12%
Neutropenia
11%
Pruritus
11%
Dyspnoea
11%
Decreased appetite
11%
Cough
10%
Dyspepsia
10%
Urinary tract infection
10%
Pain in extremity
10%
Abdominal pain upper
10%
Hypertension
9%
Influenza
9%
Amylase increased
9%
Dizziness
7%
Oedema peripheral
7%
Insomnia
7%
Dry skin
7%
Bronchitis
7%
Blood creatinine increased
7%
Leukopenia
6%
Influenza like illness
6%
Blood alkaline phosphatase increased
6%
Alopecia
6%
Blood bilirubin increased
6%
Oropharyngeal pain
6%
Sinusitis
6%
Anxiety
6%
Lymphopenia
5%
Toothache
5%
Abdominal distension
5%
Rash maculo-papular
5%
Myalgia
5%
Blood creatine phosphokinase increased
4%
Gastroenteritis
4%
Muscle spasms
3%
Face oedema
3%
Pneumonia
3%
Depression
3%
Gastrooesophageal reflux disease
3%
Bone pain
3%
Hypophosphataemia
3%
Weight increased
2%
Night sweats
2%
Hypokalaemia
2%
Vision blurred
1%
Coronary artery disease
1%
Cardiac failure acute
1%
Myocardial ischaemia
1%
Hypertensive crisis
1%
Pleural effusion
1%
Pericarditis
1%
Cholecystitis acute
1%
Cellulitis
1%
Femoral neck fracture
1%
Atrial fibrillation
1%
Hepatitis
1%
Hepatotoxicity
1%
Pregnancy of partner
1%
Unintended pregnancy
1%
Chronic kidney disease
1%
Acute kidney injury
1%
Respiratory failure
1%
Musculoskeletal chest pain
1%
Rectal cancer
1%
Haematuria
1%
Periorbital oedema
1%
Eyelid oedema
1%
Conjunctival haemorrhage
1%
Dry eye
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bosutinib
Imatinib

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Treatment B: Bosutinib four 25 mg capsule after mealExperimental Treatment1 Intervention
Bosutinib four 25 mg capsule taken after a high-fat and high-calorie breakfast for comparison 1
Group II: Treatment A: Bosutinib 100 mg capsule after meal (experimental)Experimental Treatment1 Intervention
Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast for comparison 2
Group III: Treatment A: Bosutinib 100 mg capsule after meal (active comparator)Active Control1 Intervention
Bosutinib 100 mg capsule taken after a high-fat and high-calorie breakfast for comparison 1
Group IV: Treatment C: Bosutinib 100 mg capsule after fastingActive Control1 Intervention
Bosutinib 100 mg capsule taken after an overnight fast of at least 10 hours for comparison 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bosutinib capsule
2021
Completed Phase 1
~120

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,841 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,009 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule
2022. "Evaluation of the Relative Bioavailability of Bosutinib Capsules Under Fed Condition and Estimation of Food Effect on Orally Administered Bosutinib Capsule". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05032690.
~10 spots leftby Apr 2025
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