At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Cobimetinib +1 moredrug
Likely dose
Cobimetinib 10 milligramfrom 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 1, Open-Label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Cobimetinib and Itraconazole for Healthy Participants. Completed, enrolled 16 participants across 1 site.
Detailed Summary
This open-label, 2-period, fixed sequence, drug interaction study will investigate the effect of co-administration of itraconazole on the pharmacokinetics of cobimetinib in healthy participants. Participants will receive multiple repeating doses of cobimetinib and itraconazole.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Participants
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedAug 2013
Primary CompletionOct 2013
TodayJul 2026
First PostedAug 28, 2013
Enrollment StartJul 1, 2013
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.8 years ago
Interventions
Cobimetinibdrug
10 milligram (mg) (2\* 5 mg capsules) will be administered orally on Day 1 of Period 1 and Day 4 of Period 2
Itraconazoledrug
200 mg oral solution will be administered once daily from Day 1 to Day 14 of Period 2