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CC-223

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Nov 12, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01896323CC-223 and Ketoconazole Drug-Drug Interaction StudyPHASE1 COMPLETED 14Jul 1, 2013Aug 1, 2013Nov 12, 2019 -
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Study Endpoints
Primary Endpoints
Pharmacokinetics
up to 96 hours post dose

AUC-area under the plasma concentration-time curve;

Secondary Endpoints
Adverse Events
Up to 28 days after last dose of study drug
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
CC-223EXPERIMENTALCC-223 administration on study day 1 of Period 1 and study day 5 of Period 2
KetokonazoleACTIVE_COMPARATORKetoconazole administration on study days 1 through 8 of Period 2
Interventions
NameTypeDescription
CC-223DRUGCC-223 20 mg tablets
KetoconazoleDRUGKetoconazole 400 mg tablets
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: 1. Must understand and voluntarily sign a written informed consent form before participation. 2. Must be able to communicate with the study doctor, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules. 3. Healthy...

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