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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

NCT03706898 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-01-11

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Viriom

    lead INDUSTRY

Principal Investigators

  • Alla Andreeva, PhD · Regional State Budgetary Healthcare Institution "Smolensk Regional Clinical Hospital"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-04-10
Completion
2019-04-10

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03706898 on ClinicalTrials.gov