At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Selpercatinib +2 moredrug
Likely dose
Not stated in 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 2-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Selpercatinib, Itraconazole, and 1 other intervention for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The main purpose of this study is to assess the effect of itraconazole and rifampin on how fast selpercatinib gets into the blood stream and how long it takes the body to remove it when administered in healthy participants. Information about safety and tolerability will be collected. The study is conducted in two parts and it will last up to 54 days (part 1) and 59 days (part 2), respectively, inclusive of screening period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsLoxo Oncology, Inc.
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
Primary CompletionJul 2018
Study CompletionAug 2018
First PostedApr 2022
TodayJul 2026
First PostedApr 21, 2022
Enrollment StartMay 11, 2018
Primary CompletionJul 28, 2018
Study CompletionAug 22, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 4.2 years ago
Interventions
Selpercatinibdrug
Administered orally.
Itraconazoledrug
Administered orally.
Rifampindrug
Administered orally.