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Quinidine

Phase 1

NASH - Nonalcoholic Steatohepatitis | Small molecule | Metabolic |Enanta Pharmaceuticals, Inc.|Last Updated: Dec 5, 2018

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Quinidine · 1 trial · 1 indication

Phase 1 1
NCT03610945Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy VolunteersNASH - Nonalcoholic Steatohepatitis
COMPLETED48 Analytics
PHASE1COMPLETED
Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
NASH - Nonalcoholic SteatohepatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Cmax of EDP-305 with and without coadministration with fluconazole
Up to 19 days
AUC of EDP-305 with and without coadministration with fluconazole
Up to 19 days
Cmax of EDP-305 with and without coadministration with quinidine
Up to 13 days
AUC of EDP-305 with and without coadministration with quinidine
Up to 13 days

Secondary Endpoints

Safety measured by adverse events
Up to 25 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
EDP-305 and fluconazole interaction (Part 1)EXPERIMENTAL -
EDP-305 and quinidine interaction (Part 2)EXPERIMENTAL -

Interventions

NameTypeDescription
FluconazoleDRUGSubjects will receive fluconazole once daily from Day 5 to Day 18
QuinidineDRUGSubjects will receive quinidine twice daily from Day 5 to Day 12
EDP-305DRUGSubjects will receive a single dose of EDP-305 on Day 1 and Day 14
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * An informed consent document signed and dated by the subject. * Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. * Female subjects must be of non-childbearing potential. Exclusion Criteria: * Clinically relevant evidence o...

Countries:United States
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Frequently asked questions about Quinidine

What is Quinidine used for in NASH?

Quinidine is an investigational small molecule being studied in the context of NASH, or nonalcoholic steatohepatitis. It has been evaluated in a Phase 1 clinical trial in healthy volunteers to assess drug-drug interactions. Quinidine is not approved for NASH and remains in clinical development.

Who makes Quinidine?

Quinidine is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ENTA. The company is conducting clinical research on Quinidine in the metabolic therapeutic area, specifically related to NASH.

What phase is Quinidine in?

Quinidine is in Phase 1 clinical development. A Phase 1 trial has been completed, and there are no active trials currently listed. Quinidine is investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is Quinidine in?

Quinidine has one completed clinical trial, identified as NCT03610945. This was a Phase 1 drug-drug interaction study between EDP-305, fluconazole, and Quinidine in healthy volunteers. The trial enrolled 48 participants in the United States and was controlled but not randomized or double-blinded.

Is Quinidine the same as EDP-305?

No, Quinidine is not the same as EDP-305. They are distinct compounds that were studied together in a clinical trial to evaluate drug-drug interactions. The trial, NCT03610945, assessed how these drugs interact when administered together in healthy volunteers.