Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Midazolam, Repaglinide, Dextromethorphan, Metformin, Rosuvastatin and Dolutegravir
Summary
The purpose of this study is to assess the effect of multiple doses of ganaplacide and lumefantrine combination on the substrates of cytochrome P450 (CYP) 3A4 (midazolam), CYP2C8 (repaglinide), CYP2D6 (dextromethorphan), organic cation transporter (OCT) 1, multidrug and toxin extrusion (MATE) 1 (metformin) in Cohort 1 and a substrate of the organic anion transporting polypeptide (OATP) 1B1, OATP1B3 and Breast Cancer Resistance Protein (BCRP) transporter (rosuvastatin) and an antiretroviral drug (dolutegravir) in Cohort 2. Results from this study will provide guidance on prescribing ganaplacide and lumefantrine combination when co-administered with substrates of the CYP enzymes (CYP3A4, CYP2C8 and CYP2D6) and transporters (OCT1, MATE1, OATP1B1, OATP1B3, and BCRP), and dolutegravir.
Timeline
- Start
- 2022-03-09
- Primary completion
- 2022-10-17
- Completion
- 2022-10-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dextromethorphan | Unknown | 15 mg | Oral |
| Subject | Dolutegravir | Other / unclassified | 50 mg | Oral |
| Subject | Ganaplacide | Small molecule | 400 mg | Oral |
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Midazolam | Small molecule | 2 mg | Oral |
| Subject | Repaglinide | Small molecule | 0.5 mg | Oral |
| Subject | Rosuvastatin | Small molecule | 5 mg | Oral |
| Subject | lumefantrine | Small molecule | 960 mg | Oral |