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Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of EDP-938 on the Pharmacokinetics of Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

NCT04498741•Enanta Pharmaceuticals, Inc

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 55 years

Sex

ALL

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.
•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.

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.
•For Part 1 subjects:
•Clinical history or evidence at Screening consistent with hyperkalemia, hypertension and/or diabetes mellitus
+9 more criteria

Locations (1)

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, United States

Key Dates

Start Date

July 8, 2020

Primary Completion Date

May 27, 2021

Completion Date

June 1, 2021

Last Updated

October 13, 2021

Enrollment

ACTUAL participants

Conditions

RSV Infection

Interventions

EDP-938

DRUG

EDP-938

DRUG

EDP-938

DRUG

Tacrolimus

DRUG

Dabigatran

DRUG

Rosuvastatin

DRUG

EDP-938

DRUG

Midazolam

DRUG

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

NCT03596801

RSV Infection

View study

COMPLETEDPHASE1

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

NCT06583031

RSV InfectionhMPV

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age

Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications.

A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participants