drugset / Trial / NCT04475848
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses (SAD (Part 1) and MAD (Part 2)) and food effect (FE) of RO6953958 following oral administration in healthy male participants. Part 3 (Drug-drug interaction (DDI)) will assess the safety, tolerability, and effect of RO6953958 on the PK of the cytochrome P450 (CYP) 3A substrate midazolam.
Timeline
- Start
- 2020-07-15
- Primary completion
- 2022-02-06
- Completion
- 2022-02-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 100 ug | Intravenous |
| Subject | Midazolam | Small molecule | 300 ug | Intravenous |
| Subject | RO6953958 | Unknown | 5 mg | Oral |
| Subject | RO6953958 | Unknown | 45 mg | Oral |