At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 37 enrolled
Drug / intervention
Selpercatinibdrug
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 Phase 1, Open-Label, Parallel-Cohort, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of LOXO-292
In Brief
A Phase 1 clinical trial evaluating Selpercatinib for Healthy and Renal Insufficiency. Completed, enrolled 37 participants across 6 sites.
Detailed Summary
The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy participants. The study will last up to 9 days, excluding screening.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Renal Insufficiency
CountriesUnited States
CollaboratorsLoxo Oncology, Inc.
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartDec 2018
Primary CompletionAug 2019
First PostedJul 2022
TodayJul 2026
First PostedJul 21, 2022
Enrollment StartDec 19, 2018
Primary CompletionAug 7, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.9 years ago
Interventions
Selpercatinibdrug
Administered orally