drugset / Trial / NCT03813979
Pharmacokinetics of Single-dose Dolutegravir in HIV-seronegative Subjects With Severe Hepatic Impairment Compared to Matched Controls.
Phase 4
Withdrawn
Radboud University Medical Center
Erasmus Medical Center · collabLeiden University Medical Center · collabUniversity Medical Center Groningen · collab
Non-randomizedParallel-groupOpen-labelOther
Summary
This is an open-label, parallel-group, nonrandomized, multi-centre, phase-IV, single dose trial in 8 HIV-seronegative subjects with severe hepatic impairment and 8 matched controls to assess the pharmacokinetics of a single dose of 50mg of dolutegravir in subjects with severe hepatic impairment.
Timeline
- Start
- 2020-11-15
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolutegravir | Other / unclassified | 50 mg | — |