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

NASH Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187496
• Other study ID #: EDP 305-004
• Status: Completed
• Phase: Phase 1
• First received: June 1, 2017
• Last updated: August 16, 2017
• Start date: May 11, 2017
• Est. completion date: June 14, 2017

Study information

• Verified date: August 2017
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 14, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• NASH

Intervention

Drug:
• Midazolam
Each subject will receive midazolam on Days 1 and 12.
• Caffeine
Each subject will receive caffeine on Days 1 and 12.
• Rosuvastatin
Each subject will receive rosuvastatin on Days 2 and 13.
• EDP-305
Each subject will receive EDP-305 on Days 5 through 15.

Locations

Country	Name	City	State
United States	Pharmaceutical Research Associates, Inc.,	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.		Up to 17 Days
Primary	AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.		Up to 17 days
Secondary	Cmax of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.		Up to 17 days
Secondary	AUC of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.		Up to 17 days
Secondary	Tmax of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.		Up to 17 days
Secondary	t1/2 of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.		Up to 17 days
Secondary	CL/F of midazolam, caffeine and rosuvastatin with and without the coadministration of EDP-305.		Up to 17 days
Secondary	Vd/F of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.		Up to 17 days
Secondary	AUC ratios for 1'-hydroxymidazolam/midazolam, paraxanthine/caffeine, and N-desmethyl-rosuvastatin/rosuvastatin.		Up to 17 days
Secondary	Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).		Up to 17 days