A Study Investigating the Effect of Different Approved Medications on How the Body Processes the Study Compound RO7795081
Summary
This is a single-center, non-randomized, open-label, cross-over study in healthy male and female participants. Part 1 of the study has a 2-period (a single fixed sequence) design and will investigate the impact of itraconazole on the pharmacokinetics (PK) of RO7795081 in healthy participants. A maximum of up to 25 participants will be enrolled in Part 1 and sequentially undergo Period 1 (RO7795081 alone) followed by Period 2 (RO7795081 with itraconazole). Part 2 of the study has an adaptive design with up to 4 periods (a single fixed sequence) and will investigate the impact of gemfibrozil and cyclosporine on the PK of RO7795081 in healthy participants. A maximum of up to 25 participants will be enrolled in Part 2 and sequentially undergo Period 1 (RO7795081 alone) followed by Period 2 (RO7795081 with gemfibrozil), Period 3 (RO7795081 with cyclosporine 200 mg), and finally Period 4 (RO7795081 with cyclosporine ≤600 mg).
Timeline
- Start
- 2025-02-13
- Primary completion
- 2025-06-16
- Completion
- 2025-06-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | 200 mg | Oral |
| Subject | Cyclosporine | Peptide | 600 mg | Oral |
| Subject | Gemfibrozil | Small molecule | 600 mg | Oral |
| Subject | Itraconazole | Small molecule | 200 mg | Oral |
| Subject | RO7795081 | Unknown | — | Oral |
Indications
No indication recorded.