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SAD RO7033877

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

SAD RO7033877 clinical trials

SAD RO7033877 · 1 trial · 1 indication

Phase 1 1
NCT02165332A Two-part, Single-dose, Randomized Study to Evaluate the Safety of Supra-therapeutic Doses of RO7033877 and to Investigate the Effect of RO7033877 on the QTc IntervalHealthy Volunteer
COMPLETED64 Analytics
PHASE1COMPLETED
A Two-part, Single-dose, Randomized Study to Evaluate the Safety of Supra-therapeutic Doses of RO7033877 and to Investigate the Effect of RO7033877 on the QTc Interval
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Incidence of adverse events (AEs) after single, supratherapeutic dose of RO7033877
Up to 30 days
Part 1: Pharmacokinetic parameters derived from plasma and urine concentrations, single dose of RO7033877: Area under the curve (AUC)
Day 1
Part 2: Continuous, 12-lead Holter electrocardiogram (ECG) recordings
Day -1 and 1 of each Period

Secondary Endpoints

Incidence of AEs after single IV infusion of RO7033877
Up to 9 weeks
Part 2 only: Changes in other ECG parameters, descriptive analysis
Up to 9 weeks
Part 2 only: Changes in PK/PD relationships between any effect on ECG and RO7033877 plasma concentrations, descriptive analysis
Up to 9 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Part 1: PlaceboPLACEBO_COMPARATORSaline solution, given as a minimum of a 2 hour infusion
Part 1: RO7033877EXPERIMENTALSingle ascending dose
Part 2: RO7033877EXPERIMENTALSingle-dose 4-way crossover

Interventions

NameTypeDescription
Part 1: SAD RO7033877DRUGSingle dose
Part 1: SAD placeboDRUGSingle dose
Part 2: Treatment A, RO7033877DRUGSingle dose RO7033877 and moxifloxacin placebo
Part 2: Treatment B, RO7033877DRUGSingle dose RO7033877 and moxifloxacin placebo
Part 2: Treatment C, moxifloxacinDRUGSingle dose moxifloxacin and RO7033877 placebo
Part 2: Treatment D, RO7033877 and moxifloxacin placeboDRUGSingle dose moxifloxacin placebo and RO7033877 placebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female of non-childbearing potential participants, 18 to 65 years of age, inclusive * Healthy status is defined as the absence of evidence of any clinically significant, active, or chronic disease following a detailed medical and surgical history, a complete ph...

Countries:United States
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Frequently asked questions about SAD RO7033877

What is SAD RO7033877?

SAD RO7033877 is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy volunteers. The single ascending dose (SAD) designation refers to the first part of a two-part study designed to evaluate safety and tolerability at increasing dose levels.

Who makes SAD RO7033877?

SAD RO7033877 is made by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the developer responsible for the clinical program. The compound is an investigational agent and has not been approved for any indication.

What phase is SAD RO7033877 in?

SAD RO7033877 is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. Phase 1 studies primarily assess safety, tolerability, and pharmacokinetics in small groups of participants, often healthy volunteers.

What clinical trials is SAD RO7033877 in?

SAD RO7033877 has been evaluated in a single Phase 1 trial, NCT02165332. The study was a two-part, single-dose, randomized, double-blind, placebo-controlled trial that assessed the safety of supra-therapeutic doses of RO7033877 and its effect on the QTc interval. It enrolled 64 healthy volunteers in the United States and is completed.

Is SAD RO7033877 the same as Part 1: SAD RO7033877?

Yes, SAD RO7033877 is also known as Part 1: SAD RO7033877. The alternative name reflects the single ascending dose portion of the clinical study. Both names refer to the same investigational small molecule developed by Roche Holding AG.