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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01392703
First received: July 11, 2011
Last updated: January 4, 2013
Last verified: January 2013
Results First Received: November 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Pharmacokinetic Study in Healthy Participants
Interventions: Drug: Dasatinib as tablets
Drug: Dasatinib as liquid
Drug: Dasatinib as dispersed tablets

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
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.
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.

Participant Flow for 3 periods

Period 1:   Day 1
    Dasatinib, 100 mg as Tablets + Water     Dasatinib, 100 mg as Liquid + Water     Dasatinib, 100 mg as Tablets in Orange Juice + Water  
STARTED     26     26     26  
COMPLETED     26     26     26  
NOT COMPLETED     0     0     0  

Period 2:   Day 5
    Dasatinib, 100 mg as Tablets + Water     Dasatinib, 100 mg as Liquid + Water     Dasatinib, 100 mg as Tablets in Orange Juice + Water  
STARTED     26     25 [1]   26  
COMPLETED     26     25     26  
NOT COMPLETED     0     0     0  
[1] 1 participant no longer met dosing criteria and dropped out during washout period prior to Day 5.

Period 3:   Day 9
    Dasatinib, 100 mg as Tablets + Water     Dasatinib, 100 mg as Liquid + Water     Dasatinib, 100 mg as Tablets in Orange Juice + Water  
STARTED     26     26     25  
COMPLETED     26     26     25  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Treated No text entered.

Baseline Measures
    All Treated  
Number of Participants  
[units: participants]
  78  
Age  
[units: years]
Mean ± Standard Deviation
  36.5  ± 8.75  
Age, Customized  
[units: Participants]
 
Younger than 65 years     78  
Gender  
[units: participants]
 
Female     7  
Male     71  
Race/Ethnicity, Customized  
[units: Participants]
 
Hispanic/Latino     39  
Not Hispanic/Latino     39  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Observed Concentration (Cmax) of Dasatinib   [ Time Frame: Days 1-2, Days 5-6, and Days 9-10 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Secondary:   Time of Maximum Observed Plasma Concentration (Tmax) of Dasatinib   [ Time Frame: Days 1-2, Days 5-6, and Days 9-10 ]

5.  Secondary:   Half-life of Dasatinib   [ Time Frame: Days 1-2, Days 5-6, and Days 9-10 ]

6.  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)   [ Time Frame: Continually from enrollment through Day 9 and at study discharge on Day 10 ]

7.  Secondary:   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) ]

8.  Secondary:   Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests   [ Time Frame: Day -1, Screening, and Day 9 of current treatment regimen ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01392703     History of Changes
Other Study ID Numbers: CA180-352
Study First Received: July 11, 2011
Results First Received: November 5, 2012
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board