Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

NCT04498741 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 938-006
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of tacrolimus, dabigatran, rosuvastatin and midazolam on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects

Conditions

RSV Infection

Keywords

drug-drug interaction

Outcome Measures

Primary Outcomes (8)

• Cmax of tacrolimus with and without coadministration with EDP-938

  up to 29 days

• AUC of tacrolimus with and without coadministration with EDP-938

  up to 29 days

• Cmax of dabigatran with and without coadministration with EDP-938

  up to 17 days

• AUC of dabigatran with and without coadministration with EDP-938

  up to 17 days

• Cmax of rosuvastatin with and without coadministration with EDP-938

  up to 17 days

• AUC of rosuvastatin with and without coadministration with EDP-938

  up to 17 days

• Cmax of midazolam with and without coadministration with EDP-938

  up to 17 days

• AUC of midazolam with and without coadministration with EDP-938

  up to 17 days

Secondary Outcomes (1)

• Safety measured by adverse events

  up to 34 days

Study Arms (4)

EDP-938 and tacrolimus interaction (Part 1)

EXPERIMENTAL

Drug: EDP-938; Drug: Tacrolimus

EDP-938 and dabigatran interaction (Part 2)

EXPERIMENTAL

Drug: EDP-938; Drug: Dabigatran

EDP-938 and rosuvastatin interaction (Part 3)

EXPERIMENTAL

Drug: EDP-938; Drug: Rosuvastatin

EDP-938 and midazolam interaction (Part 4)

EXPERIMENTAL

Drug: EDP-938; Drug: Midazolam

Interventions

EDP-938 DRUG

Subjects will receive EDP-938 once daily on Days 10 through 27 (Part 1)

EDP-938 and tacrolimus interaction (Part 1)

Tacrolimus DRUG

Subjects will receive tacrolimus once daily on Day 1 and Day 24

EDP-938 and tacrolimus interaction (Part 1)

Dabigatran DRUG

Subjects will receive dabigatran once daily on Day 1 and Day 13

EDP-938 and dabigatran interaction (Part 2)

Rosuvastatin DRUG

Subjects will receive rosuvastatin once daily on Day 1 and Day 13

EDP-938 and rosuvastatin interaction (Part 3)

Midazolam DRUG

Subjects will receive midazolam once daily on Day 1 and Day 16

EDP-938 and midazolam interaction (Part 4)

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.
• Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
• Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.

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.
• For Part 1 subjects:
• Clinical history or evidence at Screening consistent with hyperkalemia, hypertension and/or diabetes mellitus
• For Part 2 Subjects:
• Clinical history or evidence at screening of medically significant bleeding
• History of a mechanical heart valve placement, a thromboembolic event or clinically significant thrombotic event, an autoimmune disease, eg, systemic lupus erythematosus (SLE), or recurrent spontaneous abortions
• A platelet count \<LLN, or INR \>ULN, or aPTT \> ULN at Screening
• Ongoing daily use of nonsteroidal anti-inflammatory drugs

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead
• Pharmaceutical Research Associates: collaborator

Study Sites (1)

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

EDP-938; Tacrolimus; Dabigatran; Rosuvastatin Calcium; Midazolam

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Benzodiazepines; Benzazepines

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

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

Model Details: 4-Part Single Group study

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 4, 2020
• Study Start: July 8, 2020
• Primary Completion: May 27, 2021
• Study Completion: June 1, 2021
• Last Updated: October 13, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)