Pharmacokinetic Study Comparing Blood Levels of Dasatinib in Healthy Participants Who Received the Tablet Formulation With Those Who Received Liquid and Tablet-dispersed Formulations
Condition: Pharmacokinetic Study in Healthy Participants
Intervention: Dasatinib as tablets; Dasatinib as liquid; Dasatinib as dispersed tablets
Intervention description: 2 50-mg tablets plus 240 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day; 100 mg administered as 10 mL of liquid drug (10 mg/mL) plus 230 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day; 2 50-mg dispersed tablets in 30 mL of 100% orange juice followed by 15 mL of orange juice plus 195 mL noncarbonated, nonrefrigerated water. Liquid (oral solution), single dose, 1 day.
Intervention MeSH terms: Dasatinib
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to compare the blood levels of dasatinib in healthy participants
      who received tablet formulation with those of healthy participants who received liquid and
      tablet-dispersed formulations of the drug.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy participants, defined as having no clinically relevant deviation from normal
             in medical history, physical examination, electrocardiogram (ECG) findings, and
             clinical laboratory tests findings.

          -  Body mass index of 18 to 32 kg/m^2, inclusive

          -  Age from 18 to 55 years

          -  Men and women who were not of childbearing potential (ie, who were postmenopausal or
             surgically sterile)

          -  All women must have had a negative serum or urine pregnancy test result(minimum
             sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) at screening
             and within 24 hours prior to dosing with study drug

          -  Women must not have been breastfeeding

          -  Sexually active fertile men with female partners of childbearing potential were
             required to abide by the requirement to use effective birth control for the entire
             study and for 90 days after the date of last treatment

          -  Men must have agreed not to donate sperm for the entire study and for 90 days after
             the day of last study treatment

          -  Participants must have agreed not to make blood donations, including red blood cells,
             plasma, platelets, or whole blood, for the entire study and for 8 weeks after the day
             of last study treatment

        Key Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Current or recent (within 3 months of study drug administration) disease of the
             gastrointestinal (GI) tract that may impact drug absorption and may affect
             pharmacokinetics of the study drugs or any GI tract surgery that may impact drug
             absorption

          -  Any major surgery, as determined by the investigator, within 4 weeks of dosing in
             Period 1

          -  Blood transfusion within 4 weeks of study drug administration

          -  Donation of >400 mL 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

          -  Use of tobacco or nicotine-containing products within 6 months prior to check-in, or
             positive nicotine test at screening and/or check-in

          -  Consumption of 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; and
             HIV-1, HIV-2, or HIV antibody

          -  History of any significant drug allergy or asthma

          -  Evidence of organ dysfunction or any clinically relevant deviation from normal in
             physical examination, ECG findings, vital signs, or clinical laboratory test findings.

          -  Any of the following on 12-lead ECG prior to study drug administration, confirmed by
             repeat ECG:

               -  PR ≥210 ms

               -  QRS ≥120 ms

               -  QT ≥500 ms

               -  QTcF ≥450 ms