Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.

NCT03187496 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 305-004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy human volunteers.

Conditions

NASH

Keywords

drug-drug interaction

Outcome Measures

Primary Outcomes (2)

• Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.

  Up to 17 Days

• AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.

  Up to 17 days

Secondary Outcomes (8)

• Cmax of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

  Up to 17 days

• AUC of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

  Up to 17 days

• Tmax of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

  Up to 17 days

• t1/2 of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

  Up to 17 days

• CL/F of midazolam, caffeine and rosuvastatin with and without the coadministration of EDP-305.

  Up to 17 days

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: Midazolam; Drug: Caffeine; Drug: Rosuvastatin; Drug: EDP-305

Interventions

Midazolam DRUG

Each subject will receive midazolam on Days 1 and 12.

Single Arm

Caffeine DRUG

Each subject will receive caffeine on Days 1 and 12.

Single Arm

Rosuvastatin DRUG

Each subject will receive rosuvastatin on Days 2 and 13.

Single Arm

EDP-305 DRUG

Each subject will receive EDP-305 on Days 5 through 15.

Single Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

Midazolam; Caffeine; Rosuvastatin Calcium; EDP-305

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Xanthines; Alkaloids; Purinones; Purines; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Daniel Dickerson, MD

  Pharmaceutical Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 15, 2017
• Study Start: May 11, 2017
• Primary Completion: June 1, 2017
• Study Completion: June 14, 2017
• Last Updated: August 21, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)