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

Open Label Study to Evaluate the Safety and Pharmacokinetics of Elpida® in Healthy Subjects and Patients With Hepatic Impairment, as Well as to Assess the Impact of Food Intake and Drug-Drug Interactions in Case of Co-administration With Other Antiviral Drugs in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Viriom · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is open label, phase 1 clinical study to evaluate the safety, tolerability and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child - Pugh Class А and B), as well as to assess the impact of food intake and drug-drug interactions in case of Co-administration with other antiviral drugs in healthy subjects.

Detailed description

In medical practice HIV infection is often found associated with viral hepatitis, especially chronic hepatitis C virus (HCV). This, as well as a possible change in PK parameters in case of co-administration of Elpida® and HIV integrase inhibitors, necessitates the study of PK and safety of co-administration of Elpida® with a combination of Sofosbuvir + Daclatasvir and Dolutegravir in healthy subjects. Thus, the study to evaluates safety and pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment, as well as assesses the impact of food intake and drug-drug interactions in case of co-administration with other antiviral drugs in healthy subjects.

Conditions

• HIV-1-infection
• Hepatic Impairment

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-04-10
• Completion: 2019-04-10
• First posted: 2018-10-16
• Last updated: 2022-01-11

Locations

1 site across 1 country: Russia