drugset / Trial / 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
RandomizedFactorialOpen-labelTreatment
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.
Timeline
- Start
- 2018-10-01
- Primary completion
- 2019-04-10
- Completion
- 2019-04-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daclatasvir | Small molecule | 60 mg | — |
| Subject | Dolutegravir | Other / unclassified | 50 mg | — |
| Subject | Elsulfavirine | Small molecule | 20 mg | — |
| Subject | Sofosbuvir | Small molecule | 400 mg | — |