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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03610945
Other study ID # EDP 305-007
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 19, 2018
Est. completion date August 21, 2018

Study information

Verified date December 2018
Source Enanta Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date August 21, 2018
Est. primary completion date August 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 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.

- Clinically significant electrocardiogram abnormalities or QTcF greater than 450 ms for males and 470 ms for females at either Screening or Day -1 (Part 2 only), or any prior history of QT abnormality.

- For Part 2 subjects, the following cardiovascular abnormalities

- QRS duration >110 ms

- Incomplete right bundle branch block or any complete bundle branch block

- Heart rate <40 or >90 beats per minute (per vital sign capture while rested)

- History of unexplained syncope, structural heart disease, or clinically significant arrhythmias

- Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome

- PR interval >220 ms or any 2nd or 3rd degree AV block

- Ventricular pre-excitation

Study Design


Related Conditions & MeSH terms

  • Fatty Liver
  • NASH - Nonalcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease

Intervention

Drug:
Fluconazole
Subjects will receive fluconazole once daily from Day 5 to Day 18
Quinidine
Subjects will receive quinidine twice daily from Day 5 to Day 12
EDP-305
Subjects will receive a single dose of EDP-305 on Day 1 and Day 14
EDP-305
Subjects will receive a single dose of EDP-305 on Day 1 and Day 8

Locations

Country Name City State
United States Pharmaceutical Research Associates, Inc., Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Enanta Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax of EDP-305 with and without coadministration with fluconazole Up to 19 days
Primary AUC of EDP-305 with and without coadministration with fluconazole Up to 19 days
Primary Cmax of EDP-305 with and without coadministration with quinidine Up to 13 days
Primary AUC of EDP-305 with and without coadministration with quinidine Up to 13 days
Secondary Safety measured by adverse events Up to 25 days
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