A phase I, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of single- and multiple-ascending oral doses of RO7440688, the effect of food on the pharmacokinetics of RO7440688, and the effects of RO7440688 on midazolam pharmacokinetics in healthy volunteers

Genentech, Inc0 sites67 target enrollmentMarch 10, 2021

Overview

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37350225/ (added 08/04/2024)

Registry

who.int

Start Date

March 10, 2021

End Date

March 21, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Current participant exclusion criteria as of 05/11/2021:
•1\. Pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days of last study drug dose for subjects in the SAD and food effect stages and 28 days for subjects in the MAD and DDI stages
•2\. No comorbid conditions that may interfere with the evaluation of an investigational medical product
•3\. No history or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, or have an impact on the study results
•4\. History of severe allergic or anaphylactic reactions to human, humanized, or Current treatment with medications that are well known to prolong the QT
•Previous participant exclusion criteria:
•1\. Pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days of last study drug dose for subjects in the SAD and food effect stages and 28 days for subjects in the MAD stage
•2\. No comorbid conditions that may interfere with the evaluation of an investigational medical product
•3\. No history or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, or have an impact on the study results
•4\. History of severe allergic or anaphylactic reactions to human, humanized, or Current treatment with medications that are well known to prolong the QT