Trial · Interventional
CompletedPhase 1Registry dataA 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
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 64 participants (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Jul 2014
- Primary completion
- Nov 2014
- Completion
- Nov 2014
- First posted
- 17 Jun 2014 (estimated)
- Last update posted
- 2 Nov 2016 (estimated)
- Conditions
- Healthy Volunteer
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
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
NCT02165332Jul 2014 to Nov 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Part 1: SAD RO7033877Drug
- Part 1: SAD placeboDrug
- Part 2: Treatment A, RO7033877Drug
- Part 2: Treatment B, RO7033877Drug
- Part 2: Treatment C, moxifloxacinDrug
- Part 2: Treatment D, RO7033877 and moxifloxacin placeboDrug
Arms3
Placebo comparator
Part 1: Placebo
Saline solution, given as a minimum of a 2 hour infusion
Experimental
Part 1: RO7033877
Single ascending dose
Experimental
Part 2: RO7033877
Single-dose 4-way crossover
Primary outcomes3
Outcomes the sponsor listed as primary.
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
Secondary outcomes(4)
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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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