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Cenicriviroc

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |AbbVie Inc.|Last Updated: Jan 11, 2018

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03376841Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its MetabolitesPHASE1 COMPLETED 16 — — Jun 6, 2017Dec 17, 2017Jan 11, 20182 United States
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Study Endpoints
Primary Endpoints
Area under the plasma concentration versus time curve (AUC) from time 0 to time t (AUC0-t)
6 days (144 hours)
AUC from time 0 to infinity (AUC0-∞)
6 days (144 hours)
Maximum plasma drug concentration (Cmax)
6 days (144 hours)
Secondary Endpoints
Time of maximum plasma drug concentration (Tmax)
6 days (144 hours)
Terminal elimination rate constant
6 days (144 hours)
Terminal elimination half-life (T½)
6 days (144 hours)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Severe hepatic impairmentEXPERIMENTALCenicriviroc tablet; single-dose oral administration
Normal Hepatic functionEXPERIMENTALCenicriviroc tablet; single-dose oral administration
Interventions
NameTypeDescription
CenicrivirocDRUG1 tablet; single-dose oral administration
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria for all participants: * Sign the ICF and have the mental capability to understand it * If female, have a negative result from a serum pregnancy test at screening and a negative result from a serum or urine pregnancy test on Day -1 * If male, agree to use an effective method of co...

Countries:United States
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