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Dasatinib as

Phase 1

Undisclosed | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Feb 11, 2013

Dasatinib as target and mechanism

Molecular targetABL1, BCR
Target classInhibitor
ModalitySmall molecule

Also known as Dasatinib as tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment141

FDA Designations

No designations recorded

Dasatinib as clinical trials

Dasatinib as · 1 trial · 1 indication

Phase 1 1
NCT01392703Pharmacokinetic Study Comparing Blood Levels of Dasatinib in Healthy Participants Who Received the Tablet Formulation With Those Who Received Liquid and Tablet-dispersed FormulationsPharmacokinetic Study in Healthy Participants
COMPLETED141 Analytics
PHASE1COMPLETED
Pharmacokinetic Study Comparing Blood Levels of Dasatinib in Healthy Participants Who Received the Tablet Formulation With Those Who Received Liquid and Tablet-dispersed Formulations
Pharmacokinetic Study in Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Observed Concentration (Cmax) of Dasatinib
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.

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

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

Time of Maximum Observed Plasma Concentration (Tmax) of Dasatinib
Days 1-2, Days 5-6, and Days 9-10
Half-life of Dasatinib
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)
Continually from enrollment through Day 9 and at study discharge on Day 10
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Dasatinib, 100 mg as tablets + waterOTHERTreatment 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.
Dasatinib, 100 mg as liquid + waterOTHERTreatment 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.
Dasatinib, 100 mg as tablets in orange juice + waterOTHERTreatment 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.

Interventions

NameTypeDescription
Dasatinib as tabletsDRUG2 50-mg tablets plus 240 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day
Dasatinib as liquidDRUG100 mg administered as 10 mL of liquid drug (10 mg/mL) plus 230 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day
Dasatinib as dispersed tabletsDRUG2 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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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 yea...

Countries:United States
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Frequently asked questions about Dasatinib as

What is Dasatinib as?

Dasatinib as refers to a tablet formulation of dasatinib, a small molecule drug developed by Bristol-Myers Squibb Company (ticker BMY). It is an investigational oral therapy studied in a Phase 1 pharmacokinetic trial comparing blood levels of the tablet formulation with liquid and tablet-dispersed formulations in healthy participants.

What does Dasatinib as target?

Dasatinib as targets ABL1 and BCR. It belongs to the inhibitor class of small molecule drugs, meaning it works by inhibiting the activity of these molecular targets. This targeted mechanism underlies its development as an oral tablet formulation studied in pharmacokinetic research.

Who makes Dasatinib as?

Dasatinib as is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is responsible for the tablet formulation of dasatinib evaluated in the clinical program.

What phase is Dasatinib as in?

Dasatinib as is in Phase 1 clinical development. It is an investigational drug and is not approved. The Phase 1 program includes one completed trial with 141 participants, and no active trials are currently listed.

What clinical trials is Dasatinib as in?

Dasatinib as has been studied in one completed Phase 1 trial, NCT01392703. This pharmacokinetic study compared blood levels of dasatinib in healthy participants who received the tablet formulation with those who received liquid and tablet-dispersed formulations. It enrolled 141 participants in the United States and was controlled and randomized.

Is Dasatinib as the same as Dasatinib as tablets?

Yes, Dasatinib as is also known as Dasatinib as tablets. Both names refer to the same tablet formulation of dasatinib developed by Bristol-Myers Squibb Company under the ticker BMY.