A Phase 1 interventional study of Part 1: SAD RO7033877 and Part 1: SAD placebo in Healthy Volunteer, sponsored by Hoffmann-La Roche. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 1 and Interventional
This is a two-part study to evaluate the safety and tolerability of supratherapeutic doses of RO7033877 (Part 1) and to investigate the effect of RO7033877 on the QTc interval in healthy volunteers (Part 2). Part 1 is a single ascending dose, randomized, observer-blind, placebo-controlled study to determine the safety tolerability and pharmacokinetics of a supratherapeutic dose to be used in Part 2. Participants will be randomized in up to 8 cohorts to receive a single dose of either RO7033877 or placebo. Part 2 will be a single dose, randomized, double-blind, double dummy, placebo-controlled, positive control, 4-way crossover study. Part 2 will evaluate whether a single therapeutic or supratherapeutic dose of RO7033877 has a threshold pharmacologic effect on cardiac repolarization, as detected by changes in the QT/QTc interval measured by electrocardiogram (ECG). Pharmacokinetic parameters will be assessed for Parts 1 and 2, continuous ECG recordings will be evaluated in Part 2.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for Part 2 only:
Saline solution, given as a minimum of a 2 hour infusion
Drug: Part 1: SAD placebo
Single ascending dose
Drug: Part 1: SAD RO7033877
Single-dose 4-way crossover
Drug: Part 2: Treatment A, RO7033877 · Drug: Part 2: Treatment B, RO7033877 · Drug: Part 2: Treatment C, moxifloxacin · Drug: Part 2: Treatment D, RO7033877 and moxifloxacin placebo
Single dose
Single dose
Single dose RO7033877 and moxifloxacin placebo
Single dose RO7033877 and moxifloxacin placebo
Single dose moxifloxacin and RO7033877 placebo
Single dose moxifloxacin placebo and RO7033877 placebo
Part 1: Incidence of adverse events (AEs) after single, supratherapeutic dose of RO7033877
Time frame: Up to 30 days
Part 1: Pharmacokinetic parameters derived from plasma and urine concentrations, single dose of RO7033877: Area under the curve (AUC)
Time frame: Day 1
Part 2: Continuous, 12-lead Holter electrocardiogram (ECG) recordings
Time frame: Day -1 and 1 of each Period
Incidence of AEs after single IV infusion of RO7033877
Time frame: Up to 9 weeks
Part 2 only: Changes in other ECG parameters, descriptive analysis
Time frame: Up to 9 weeks
Part 2 only: Changes in PK/PD relationships between any effect on ECG and RO7033877 plasma concentrations, descriptive analysis
Time frame: Up to 9 weeks
Part 2: Area under the concentration-time curve (AUC) of RO7033877
Time frame: Day 1 of each Period
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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