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

Sponsor
Enanta Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT04498741
Collaborator
Pharmaceutical Research Associates (Other)
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Study Details

Study Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
4-Part Single Group study4-Part Single Group study
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Jul 8, 2020
Actual Primary Completion Date :
May 27, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: EDP-938 and tacrolimus interaction (Part 1)

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

Drug: Tacrolimus
Subjects will receive tacrolimus once daily on Day 1 and Day 24

Experimental: EDP-938 and dabigatran interaction (Part 2)

Drug: EDP-938
Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 2)

Drug: Dabigatran
Subjects will receive dabigatran once daily on Day 1 and Day 13

Experimental: EDP-938 and rosuvastatin interaction (Part 3)

Drug: EDP-938
Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 3)

Drug: Rosuvastatin
Subjects will receive rosuvastatin once daily on Day 1 and Day 13

Experimental: EDP-938 and midazolam interaction (Part 4)

Drug: EDP-938
Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4)

Drug: Midazolam
Subjects will receive midazolam once daily on Day 1 and Day 16

Outcome Measures

Primary Outcome Measures

  1. Cmax of tacrolimus with and without coadministration with EDP-938 [up to 29 days]

  2. AUC of tacrolimus with and without coadministration with EDP-938 [up to 29 days]

  3. Cmax of dabigatran with and without coadministration with EDP-938 [up to 17 days]

  4. AUC of dabigatran with and without coadministration with EDP-938 [up to 17 days]

  5. Cmax of rosuvastatin with and without coadministration with EDP-938 [up to 17 days]

  6. AUC of rosuvastatin with and without coadministration with EDP-938 [up to 17 days]

  7. Cmax of midazolam with and without coadministration with EDP-938 [up to 17 days]

  8. AUC of midazolam with and without coadministration with EDP-938 [up to 17 days]

Secondary Outcome Measures

  1. Safety measured by adverse events [up to 34 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts 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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pharmaceutical Research Associates, Inc., Lenexa Kansas United States 66219

Sponsors and Collaborators

  • Enanta Pharmaceuticals
  • Pharmaceutical Research Associates

Investigators

  • Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enanta Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT04498741
Other Study ID Numbers:
  • EDP 938-006
First Posted:
Aug 4, 2020
Last Update Posted:
Oct 13, 2021
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Enanta Pharmaceuticals
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021