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CompletedNCT03213145Updated Nov 6, 2017

Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers

A Phase 1 interventional study of intraconazole and Rifampin in NASH - Nonalcoholic Steatohepatitis, sponsored by Enanta Pharmaceuticals, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-06.

Sponsored by Enanta Pharmaceuticals, Inc · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Aug 2017, 9 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.

02

Conditions studied

  • NASH - Nonalcoholic Steatohepatitis

Keywords

  • drug-drug interaction
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's enrollment of 48 is below the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

Enanta Pharmaceuticals, Inc is the lead sponsor of 45 studies on the registry; 2 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Clinically relevant evidence or history of illness or disease.
  • Pregnant or nursing females.
  • History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
  • A positive urine drug screen at screening or Day -1.
  • Current tobacco smokers or use of tobacco within 3 months prior to screening.
  • Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
  • History of regular alcohol consumption.
  • Participation in a clinical trial within 30 days prior to the first dose of study drug.
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Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Part 1

    Drug: intraconazole · Drug: EDP 305

  • Experimental
    Part 2

    Drug: Rifampin · Drug: EDP 305

Interventions

  • Drugintraconazole

    Subjects will receive itraconazole once daily from Day 5 through Day18

  • DrugRifampin

    Subjects will receive rifampin once daily from Day 5 through Day 16

  • DrugEDP 305

    Subjects will receive EDP 305 once daily on Day 1 and Day 14

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What researchers measure

Primary outcomes

  1. Cmax of EDP-305 with and without coadministration with itraconazole

    Time frame: Up to 19 days

  2. AUC of EDP-305 with and without coadministration with itraconazole

    Time frame: Up to 19 days

  3. Cmax of EDP-305 with and without coadministration with rifampin

    Time frame: Up to 17 days

  4. AUC of EDP-305 with and without coadministration with rifampin

    Time frame: Up to 17 days

Secondary outcomes

  1. Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).

    Time frame: Up to 19 days

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Study locations

1 site
  • Pharmaceutical Research Associates, Inc.,
    Lenexa, Kansas 66219, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03213145
Lead sponsor
Enanta Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Jul 11, 2017
Start date
Jul 11, 2017
Primary completion
Aug 10, 2017
Completion
Sep 7, 2017
Last update
Nov 6, 2017

Study contacts

Enanta Pharmaceuticals, Inc
study director · Enanta Pharmaceuticals, Ind

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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