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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dasatinib, 100 mg as tablets + water | Other | 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. |
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| Dasatinib, 100 mg as liquid + water | Other | 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. |
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| Dasatinib, 100 mg as tablets in orange juice + water | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib as tablets | Drug | 2 50-mg tablets plus 240 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Dasatinib | Single-dose pharmacokinetic parameters, including Cmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data. | Days 1-2, Days 5-6, and Days 9-10 |
| Area Under the Plasma Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration (AUC[0-T])of Dasatinib | Single-dose pharmacokinetic, such as AUC(0-T),parameters were derived using noncompartmental methods from plasma dasatinib concentration-time data. | Days 1-2, Days 5-6, and Days 9-10 |
| Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-INF]) of Dasatinib | Single-dose pharmacokinetic parameters, such as AUC(0-INF) were derived using noncompartmental methods from plasma dasatinib concentration-time data. | Days 1-2, Days 5-6, and Days 9-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Maximum Observed Plasma Concentration (Tmax) of Dasatinib | Single-dose pharmacokinetic parameters, such as Tmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data. | Days 1-2, Days 5-6, and Days 9-10 |
| Half-life of Dasatinib |
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Key Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Discoveries Inc. | San Antonio | Texas | 78209 | United States |
A total of 141 participants were enrolled, of which 78 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib, 100 mg as Tablets + Water | Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Day 1 |
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| 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 |
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| 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. |
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| Days 1-2, Days 5-6, and Days 9-10 |
| 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) | 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. | Continually from enrollment through Day 9 and at study discharge on Day 10 |
| Number of Participants With Clinically Significant Changes in Vital Signs or Electrocardiogram (ECG) Findings | 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. | Day -1, Screening, and Days 1, 5, 9 and 10 (at study discharge) |
| Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests | 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. | Day -1, Screening, and Day 9 of current treatment regimen |
| Dasatinib, 100 mg as Liquid + Water |
Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period. |
| FG002 | Dasatinib, 100 mg as Tablets in Orange Juice + Water | Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. |
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| NOT COMPLETED |
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| Day 5 |
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| Day 9 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Treated |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Concentration (Cmax) of Dasatinib | Single-dose pharmacokinetic parameters, including Cmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data. | All participants who received at least 1 dose of any study drug and had pharmacokinetic data available. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Days 1-2, Days 5-6, and Days 9-10 |
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| Primary | Area Under the Plasma Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration (AUC[0-T])of Dasatinib | Single-dose pharmacokinetic, such as AUC(0-T),parameters were derived using noncompartmental methods from plasma dasatinib concentration-time data. | All participants who received at least 1 dose of any study drug and had pharmacokinetic data available. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Days 1-2, Days 5-6, and Days 9-10 |
| |||||||||||||||||||||||||||||||||
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-INF]) of Dasatinib | Single-dose pharmacokinetic parameters, such as AUC(0-INF) were derived using noncompartmental methods from plasma dasatinib concentration-time data. | All participants who received at least 1 dose of any study drug and had pharmacokinetic data available. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Days 1-2, Days 5-6, and Days 9-10 |
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| Secondary | Time of Maximum Observed Plasma Concentration (Tmax) of Dasatinib | Single-dose pharmacokinetic parameters, such as Tmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data. | All participants who received at least 1 dose of any study drug and had pharmacokinetic data available. | Posted | Median | Full Range | Hours | Days 1-2, Days 5-6, and Days 9-10 |
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| Secondary | Half-life of Dasatinib | All participants who received at least 1 dose of any study drug and had pharmacokinetic data available. | Posted | Mean | Standard Deviation | Hours | Days 1-2, Days 5-6, and Days 9-10 |
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| Secondary | 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) | 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. | All participants who received at least 1 dose of any study drug. | Posted | Number | Participants | Continually from enrollment through Day 9 and at study discharge on Day 10 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs or Electrocardiogram (ECG) Findings | 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. | All participants who received at least 1 dose of any study drug. | Posted | Number | Participants | Day -1, Screening, and Days 1, 5, 9 and 10 (at study discharge) |
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| Secondary | Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests | 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. | All participants who received at least 1 dose of any study drug. | Posted | Number | Participants | Day -1, Screening, and Day 9 of current treatment regimen |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dasatinib, 100 mg as Tablets + Water | Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period. | 0 | 78 | 42 | 78 | ||
| EG001 | Dasatinib, 100 mg as Liquid + Water | Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period. | 0 | 77 | 44 | 77 | ||
| EG002 | Dasatinib, 100 mg as Tablets in Orange Juice + Water | Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. | 0 | 77 | 35 | 77 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| D013607 | Tablets |
| D005440 | Fluid Therapy |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. |
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Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
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| OG001 |
| Dasatinib, 100 mg as Liquid + Water |
Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period. |
| OG002 | Dasatinib, 100 mg as Tablets in Orange Juice + Water | Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. |
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| OG002 | Dasatinib, 100 mg as Tablets in Orange Juice + Water | Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. |
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