drugset / Trial / NCT04475848

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of RO6953958 in Healthy Participants

NCT04475848 ↗

Phase 1 Completed 88 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
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

Indications