Pharmacokinetic Study Comparing Blood Levels of Dasatinib in Healthy Participants Who Received the Tablet Formulation With Those Who Received Liquid and Tablet-dispersed Formulations

NCT ID: NCT01392703

Last Updated: 2013-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-09-30

Brief 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.

Conditions

Pharmacokinetic Study in Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Dasatinib, 100 mg as tablets + water

Treatment A. Participants were randomized to and received treatment in 1 of 6 sequences (ABC, ACB, BCA, BAC, CAB, or CBA), administered over 3 1-day treatment periods (Days 1, 5, and 9), with treatment changing to next in the sequence at start of each new period. A 3-day washout period followed treatment periods 1 and 2.

Group Type: OTHER

Dasatinib as tablets

Intervention Type: DRUG

2 50-mg tablets plus 240 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day

Dasatinib, 100 mg as liquid + water

Treatment B. Participants were randomized to and received treatment in 1 of 6 sequences (ABC, ACB, BCA, BAC, CAB, or CBA), administered over 3 1-day treatment periods (Days 1, 5, and 9), with treatment changing to next in the sequence at start of each new period. A 3-day washout period followed treatment periods 1 and 2.

Group Type: OTHER

Dasatinib as liquid

Intervention Type: DRUG

100 mg administered as 10 mL of liquid drug (10 mg/mL) plus 230 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day

Dasatinib, 100 mg as tablets in orange juice + water

Treatment C. Participants were randomized to and received treatment in 1 of 6 sequences (ABC, ACB, BCA, BAC, CAB, or CBA), administered over 3 1-day treatment periods (Days 1, 5, and 9), with treatment changing to next in the sequence at start of each new period. A 3-day washout period followed treatment periods 1 and 2.

Group Type: OTHER

Dasatinib as dispersed tablets

Intervention Type: DRUG

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.

Interventions

Dasatinib as tablets

2 50-mg tablets plus 240 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day

Intervention Type: DRUG

Dasatinib as liquid

100 mg administered as 10 mL of liquid drug (10 mg/mL) plus 230 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day

Intervention Type: DRUG

Dasatinib as dispersed tablets

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 Type: DRUG

Other Intervention Names

Dasatinib/BMS-354825; Dasatinib/BMS-354825; Dasatinib/BMS-354825

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Healthcare Discoveries Inc.

San Antonio, Texas, United States

Countries

United States

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CA180-352

Identifier Type: -

Identifier Source: org_study_id