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Completed

NCT Number: NCT01392703

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

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.

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Key information

Conditions

Pharmacokinetic Study in Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Healthcare Discoveries Inc.

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dasatinib as tablets

Drug

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

Other names: Dasatinib/BMS-354825

Dasatinib as liquid

Drug

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

Other names: Dasatinib/BMS-354825

Dasatinib as dispersed tablets

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.

Other names: Dasatinib/BMS-354825

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of Dasatinib

    Time frame: Days 1-2, Days 5-6, and Days 9-10

    Single-dose pharmacokinetic parameters, including Cmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data.

  2. Area Under the Plasma Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration (AUC[0-T])of Dasatinib

    Time frame: Days 1-2, Days 5-6, and Days 9-10

    Single-dose pharmacokinetic, such as AUC(0-T),parameters were derived using noncompartmental methods from plasma dasatinib concentration-time data.

  3. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-INF]) of Dasatinib

    Time frame: Days 1-2, Days 5-6, and Days 9-10

    Single-dose pharmacokinetic parameters, such as AUC(0-INF) were derived using noncompartmental methods from plasma dasatinib concentration-time data.

Secondary outcomes

  1. Time of Maximum Observed Plasma Concentration (Tmax) of Dasatinib

    Time frame: Days 1-2, Days 5-6, and Days 9-10

    Single-dose pharmacokinetic parameters, such as Tmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data.

  2. Half-life of Dasatinib

    Time frame: Days 1-2, Days 5-6, and Days 9-10

  3. Number of Participants With at Least 1 Adverse Event (AE), With at Least 1 Treatment-related AE, Who Discontinued Due to AEs, and With at Least 1 Serious Adverse Event (SAE)

    Time frame: Continually from enrollment through Day 9 and at study discharge on Day 10

    An AE is any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant who has received an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE is an untoward medical event that at any dose results in death, persistent or significant disability/incapacity; is life-threatening or a congenital anomaly/birth defect; or requires or prolongs hospitalization; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention.

  4. Number of Participants With Clinically Significant Changes in Vital Signs or Electrocardiogram (ECG) Findings

    Time frame: Day -1, Screening, and Days 1, 5, 9 and 10 (at study discharge)

    Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. ECG findings were recorded after the participant had been supine for at least 5 minutes. Clinically significant as reported by principal investigator.

  5. Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests

    Time frame: Day -1, Screening, and Day 9 of current treatment regimen

    Criteria for normal: bilirubin (0.2 to 1.3 mg/dL); lactate dehydrogenase (101 to 227 U/L); eosinophils (0.06 to 0.87*103 c/μL); erythrocytes (4.2 to 5.8*10^6 c/μL). Participants were required to fast for a minimum of 4 hours prior to the collection of specimens for clinical laboratory tests at screening and for at least 8 hours prior to collection on Day -1. Marked abnormalities were reported for the treatment regiment that participants received just prior to clinical laboratory testing.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 12, 2011
Registry last updated
Feb 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.