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Open-label, Randomized, 3-period, 3-treatment Crossover, Bioequivalence Study Comparing Dasatinib (BMS-354825) Liquid Formulation and the Dispersed Tablet Formulation Relative to the Reference Tablet Formulation in Health Subjects


Phase 1
18 Years
55 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Open-label, Randomized, 3-period, 3-treatment Crossover, Bioequivalence Study Comparing Dasatinib (BMS-354825) Liquid Formulation and the Dispersed Tablet Formulation Relative to the Reference Tablet Formulation in Health Subjects


Inclusion Criteria:



- Healthy subjects as determined by no clinically significant deviation from normal in
medical history, physical examination, ECGs, and clinical laboratory determinations

- Body mass index (BMI) of 18 to 32 kg/m2 , inclusive

- Adults aged 18 to 55 years

Exclusion Criteria:

- Any significant acute or chronic medical illness

- Current or recent (within 3 months of study drug administration) gastrointestinal
disease that may impact drug absorption and may affect PK of the study drugs or any
gastro (GI) surgery that may impact drug absorption

- Blood transfusion within 4 weeks of study drug administration

- Donation of >400mL of blood within 8 weeks prior to study dosing or donation of
plasma within 4 weeks prior to study dosing

- Inability to tolerate oral medication

- Inability to tolerate orange juice

- Inability to undergo venipuncture and/or tolerate venous access

- Any major surgery within 4 weeks of study drug administration

- Use of tobacco or nicotine-containing products within 6 months prior to check-in, or
positive nicotine test at screening and/or check-in

- Subjects who drink more than 3 cups of coffee or other caffeine containing products a
day, or 5 cups of tea a day

- Recent (within 6 months of study drug administration) drug or alcohol abuse

- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human
immunodeficiency virus (HIV-1), -2 antibody

- History of any significant drug allergy or asthma

- Women who are pregnant or breastfeeding and/or unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Outcome Measure:

Single-dose pharmacokinetic parameters maximum observed concentration (Cmax) of Dasatinib (BMS-354825) derived from serum concentration versus time data

Outcome Time Frame:

10 days during the cross-over period

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-352

NCT ID:

NCT01392703

Start Date:

July 2011

Completion Date:

September 2011

Related Keywords:

  • Leukemia
  • Leukemia

Name

Location

Healthcare Discoveries Inc.San Antonio, Texas  78209