NCT03706898View on ClinicalTrials.gov

Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 1, 2018

Primary Completion Date

April 10, 2019

Study Completion Date

April 10, 2019

Conditions
HIV-1-infectionHepatic Impairment
Interventions
DRUG

Elpida®

Elpida® capsules, 20mg

DRUG

Dolutegravir

Dolutegravir, film-coated tablets, 50mg

DRUG

Sofosbuvir

Sofosbuvir, film-coated tablets, 400mg

DRUG

Daclatasvir

Daclatasvir, film-coated tablets, 60mg

Trial Locations (1)

214018

"Regional State Budgetary Healthcare Institution Smolensk Regional Clinical Hospital", Smolensk

Sponsors

Lead Sponsor

Viriom
All Listed Sponsors
lead

Viriom

INDUSTRY

NCT03706898 - Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs | Biotech Hunter | Biotech Hunter