Clinical trial NCT03187496: Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NASH
Keywords: drug-drug interaction
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2017-06-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.
timeFrame: Up to 17 Days
measure: AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.
timeFrame: Up to 17 days
Secondary outcomes:
measure: Cmax of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.
timeFrame: Up to 17 days
measure: AUC of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.
timeFrame: Up to 17 days
measure: Tmax of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.
timeFrame: Up to 17 days
measure: t1/2 of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.
timeFrame: Up to 17 days
measure: CL/F of midazolam, caffeine and rosuvastatin with and without the coadministration of EDP-305.
timeFrame: Up to 17 days
measure: Vd/F of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.
timeFrame: Up to 17 days
measure: AUC ratios for 1'-hydroxymidazolam/midazolam, paraxanthine/caffeine, and N-desmethyl-rosuvastatin/rosuvastatin.
timeFrame: Up to 17 days
measure: Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
timeFrame: Up to 17 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pharmaceutical Research Associates, Inc.,
state: Kansas
Study officials:
affiliation: Pharmaceutical Research Associates
name: Daniel Dickerson, MD
role: PRINCIPAL_INVESTIGATOR
References: