drugset / Trial / NCT01695954
Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz
Phase 1
Completed
34 enrolled
NYU Langone Health
Kowa Pharmaceuticals America, Inc. · collabNew York City Health and Hospitals Corporation · collabUniversity at Buffalo · collab
Non-randomizedParallel-groupOpen-labelOther
Summary
The main goal of this study is to determine how taking efavirenz affects the levels of pitavastatin in the bloodstream when both drugs are taken together and to see how darunavir with ritonavir affects the levels of pitavastatin in the bloodstream. Secondary goals are to see how taking pitavastatin affects the levels in the blood of efavirenz when both drugs are taken together and to see how taking pitavastatin affects the levels in the blood of darunavir.
Timeline
- Start
- 2012-05
- Primary completion
- 2013-01
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darunavir | Small molecule | 800 mg | Oral |
| Subject | Efavirenz | Other / unclassified | 600 mg | Oral |
| Subject | Pitavastatin | Small molecule | 2 mg | Oral |
| Background | Ritonavir | Other / unclassified | 100 mg | Oral |