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SAD RO7033877

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Nov 2, 2016

Target and mechanism

ModalitySmall molecule

Also known as Part 1: SAD RO7033877

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

Clinical trial landscape

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
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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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