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Cenicriviroc

Phase 2

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

Cenicriviroc development status

Highest phase Phase 2 run by Tobira Therapeutics, Inc. (NCT03059446)
Phase scored for ABBVPhase 1
Registered trials 2 across 2 sponsors since Feb 2017

Cenicriviroc target and mechanism

Molecular targetCCR2, CCR5
Target classAntagonist
ModalitySmall molecule

Also known as CVC

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Cenicriviroc clinical trials

Cenicriviroc · 1 trial · 1 indication

Phase 1 1
NCT03376841Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its MetabolitesHepatic Impairment
COMPLETED16 Analytics
PHASE1COMPLETED
Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its Metabolites
Hepatic ImpairmentUnlock trial analytics

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 to 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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Frequently asked questions about Cenicriviroc

What is Cenicriviroc?

Cenicriviroc is an investigational small molecule developed by AbbVie Inc. (ticker ABBV) for hepatic impairment. It is a CCR2 and CCR5 antagonist and has been studied in a Phase 1 clinical trial. It is not an approved therapy and remains in clinical development.

What is Cenicriviroc used for in hepatic impairment?

Cenicriviroc has been evaluated in hepatic impairment, specifically to assess how severe hepatic impairment affects the pharmacokinetics of the drug and its metabolites. The relevant study was a Phase 1 trial conducted in the United States. Cenicriviroc is investigational and has not been approved for any use.

What does Cenicriviroc target?

Cenicriviroc targets CCR2 and CCR5, two chemokine receptors, and acts as an antagonist at both. By blocking these receptors, the small molecule interferes with CCR2 and CCR5 mediated signaling. This mechanism underlies its investigation in hepatic impairment.

Who makes Cenicriviroc?

Cenicriviroc is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the sponsor associated with the clinical development of this small molecule CCR2 and CCR5 antagonist. The drug remains investigational.

What phase is Cenicriviroc in?

Cenicriviroc is in Phase 1 development. The single recorded trial, NCT03376841, was a Phase 1 study that has been completed. Cenicriviroc is investigational and is not FDA approved for any indication.

What clinical trials is Cenicriviroc in?

Cenicriviroc has been studied in one clinical trial, NCT03376841, titled Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its Metabolites. It was a completed Phase 1 controlled study with 16 enrolled participants, conducted in the United States, and included healthy volunteers.