Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects

Sponsor
Enanta Pharmaceuticals, Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05594615
Collaborator
(none)
24
1
1
26
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Study Details

Study Description

Brief Summary

A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A NON-RANDOMIZED, MULTIPLE-DOSE, OPEN-LABEL, SINGLE SEQUENCE STUDY TO EVALUATE THE EFFECT OF CONCOMITANT ADMINISTRATION OF EDP-235 ON THE PHARMACOKINETICS AND SAFETY OF MIDAZOLAM, CAFFEINE, AND ROSUVASTATIN IN HEALTHY PARTICIPANTS
Actual Study Start Date :
Oct 6, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: EDP-235, midazolam, rosuvastatin and caffeine

Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days

Drug: EDP-235
Subjects will receive EDP-235 once daily on Days 5-15

Drug: Midazolam
Subjects will receive midazolam once daily on Days 1 and 12

Drug: Rosuvastatin
Subjects will receive rosuvastatin once daily on Days 2 and 13

Drug: Caffeine
Subjects will receive caffeine once daily on Days 1 and 12

Outcome Measures

Primary Outcome Measures

  1. Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235 [Up to 17 Days]

  2. AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235 [Up to 17 Days]

Secondary Outcome Measures

  1. Safety measured by adverse events [Up to 22 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-235. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

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

  • History of drug allergy to midazolam, caffeine, or rosuvastatin

Contacts and Locations

Locations

Site City State Country Postal Code
1 ICON, plc. Salt Lake City Utah United States 84124

Sponsors and Collaborators

  • Enanta Pharmaceuticals, Inc

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enanta Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT05594615
Other Study ID Numbers:
  • EDP 235-003
First Posted:
Oct 26, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Enanta Pharmaceuticals, Inc
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022