At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 54 enrolled
Drug / intervention
Selumetinib +2 moredrug
Likely dose
Selumetinib 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Double-blind (Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), Placebo-controlled, Open-Label (Moxifloxacin) Positive-controlled, Randomized, Three-period Crossover Study to Assess the Effects of Single Oral Dose of Selumetinib (75 mg) on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Aged 18 to 45 Years
In Brief
A Phase 1 clinical trial evaluating Selumetinib, Moxifloxacin, and 1 other intervention for Solid Tumours. Completed, enrolled 54 participants across 1 site.
Detailed Summary
Study to assess the effect of Selumetinib \[AZD6244; ARRY-142886\] \[Hyd-Sulfate\]), on QTc interval in healthy male volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumours
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMar 2014
Primary CompletionAug 2014
TodayJul 2026
First PostedFeb 6, 2014
Enrollment StartMar 1, 2014
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 12.4 years ago
Interventions
Selumetinibdrug
Volunteers will receive 75 mg selumetinib oral dose (Treatment A)
Moxifloxacindrug
Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)
selumetinib placebodrug
Volunteers will receive selumetinib placebo oral dose (Treatment C)