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

RSV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498741
• Other study ID #: EDP 938-006
• Status: Completed
• Phase: Phase 1
• Start date: July 8, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2020
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 1, 2021
• Est. primary completion date: May 27, 2021
• 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.

• 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

• 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

• For Part 3 subjects:

• AST and/or ALT >ULN at Screening

• For Part 4 subjects:

• History of glaucoma

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• RSV Infection

Intervention

Drug:
• EDP-938
Subjects will receive EDP-938 once daily on Days 10 through 27 (Part 1)
• EDP-938
Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 2)
• EDP-938
Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 3)
• Tacrolimus
Subjects will receive tacrolimus once daily on Day 1 and Day 24
• Dabigatran
Subjects will receive dabigatran once daily on Day 1 and Day 13
• Rosuvastatin
Subjects will receive rosuvastatin once daily on Day 1 and Day 13
• EDP-938
Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4)
• Midazolam
Subjects will receive midazolam once daily on Day 1 and Day 16

Locations

Country	Name	City	State
United States	Pharmaceutical Research Associates, Inc.,	Lenexa	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals	Pharmaceutical Research Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of tacrolimus with and without coadministration with EDP-938		up to 29 days
Primary	AUC of tacrolimus with and without coadministration with EDP-938		up to 29 days
Primary	Cmax of dabigatran with and without coadministration with EDP-938		up to 17 days
Primary	AUC of dabigatran with and without coadministration with EDP-938		up to 17 days
Primary	Cmax of rosuvastatin with and without coadministration with EDP-938		up to 17 days
Primary	AUC of rosuvastatin with and without coadministration with EDP-938		up to 17 days
Primary	Cmax of midazolam with and without coadministration with EDP-938		up to 17 days
Primary	AUC of midazolam with and without coadministration with EDP-938		up to 17 days
Secondary	Safety measured by adverse events		up to 34 days