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OpenTrials
Completed

NCT Number: NCT05594615

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON, plc.

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EDP-235

Drug

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

midazolam

Drug

Subjects will receive midazolam once daily on Days 1 and 12

Rosuvastatin

Drug

Subjects will receive rosuvastatin once daily on Days 2 and 13

Caffeine

Drug

Subjects will receive caffeine once daily on Days 1 and 12

Primary outcomes

  1. Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235

    Time frame: Up to 17 Days

  2. AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235

    Time frame: Up to 17 Days

Secondary outcomes

  1. Safety measured by adverse events

    Time frame: Up to 22 days

Sponsors and collaborators

Lead sponsor

Enanta Pharmaceuticals, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2022
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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