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Cenicriviroc

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

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 Impairment
NCT0337684116
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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 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 used for in hepatic impairment?

Cenicriviroc is being studied for use in hepatic impairment, specifically to evaluate how severe liver impairment affects the drug's pharmacokinetics. It is an investigational small molecule in Phase 1 clinical development. The drug is not approved and remains under study for this condition.

Who makes Cenicriviroc?

Cenicriviroc is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical research on this small molecule for hepatic impairment.

What phase is Cenicriviroc in?

Cenicriviroc is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The current Phase 1 trial focuses on hepatic impairment and has been completed.

What clinical trials is Cenicriviroc in?

Cenicriviroc has one completed Phase 1 clinical trial, identified as NCT03376841. The trial, titled "Impact of Severe Hepatic Impairment on Pharmacokinetics of Cenicriviroc and Its Metabolites," enrolled 16 participants in the United States and included healthy volunteers.

Is Cenicriviroc FDA approved?

Cenicriviroc is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for hepatic impairment. The drug remains under study, and no approval status has been established.