Skip to main content
OpenTrials
Completed

NCT Number: NCT03187496

Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.

A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy human volunteers.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, 66219, 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.
  • Female subjects must be of non-childbearing potential.

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.

Treatment and study plan

midazolam

Drug

Each subject will receive midazolam on Days 1 and 12.

Caffeine

Drug

Each subject will receive caffeine on Days 1 and 12.

Rosuvastatin

Drug

Each subject will receive rosuvastatin on Days 2 and 13.

EDP-305

Drug

Each subject will receive EDP-305 on Days 5 through 15.

Primary outcomes

  1. Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.

    Time frame: Up to 17 Days

  2. AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.

    Time frame: Up to 17 days

Secondary outcomes

  1. Cmax of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

    Time frame: Up to 17 days

  2. AUC of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

    Time frame: Up to 17 days

  3. Tmax of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

    Time frame: Up to 17 days

  4. t1/2 of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

    Time frame: Up to 17 days

  5. CL/F of midazolam, caffeine and rosuvastatin with and without the coadministration of EDP-305.

    Time frame: Up to 17 days

  6. Vd/F of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

    Time frame: Up to 17 days

  7. AUC ratios for 1'-hydroxymidazolam/midazolam, paraxanthine/caffeine, and N-desmethyl-rosuvastatin/rosuvastatin.

    Time frame: Up to 17 days

  8. Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).

    Time frame: Up to 17 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-305 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Human Volunteers

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2017
Registry last updated
Aug 21, 2017

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.

Published trials that share one or more normalized conditions with this study.