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

A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-305 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Human Volunteers

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.

Study Overview

• Status: Completed
• Conditions: NASH
• Intervention / Treatment: Drug: Midazolam; Drug: Caffeine; Drug: Rosuvastatin; Drug: EDP-305

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single Arm	Drug: Midazolam; Each subject will receive midazolam on Days 1 and 12.; Drug: Caffeine; Each subject will receive caffeine on Days 1 and 12.; Drug: Rosuvastatin; Each subject will receive rosuvastatin on Days 2 and 13.; Drug: EDP-305; Each subject will receive EDP-305 on Days 5 through 15.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Vd/F of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.	Up to 17 days
AUC ratios for 1'-hydroxymidazolam/midazolam, paraxanthine/caffeine, and N-desmethyl-rosuvastatin/rosuvastatin.	Up to 17 days
Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).	Up to 17 days

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2017
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): June 14, 2017

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (ACTUAL): June 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: drug-drug interaction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Purinergic Antagonists; Purinergic Agents; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Midazolam; Rosuvastatin Calcium; Caffeine
• Other Study ID Numbers: EDP 305-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: When the clinical study report has been submitted to the appropriate Regulatory authorities, a lay person summary will be provided to all study subjects by mail or email.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No