At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 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.
Open-label, Nonrandomized, Single-dose, Parallel-group, Safety, Tolerance, and Pharmacokinetic Study of LOXO-292 Administered to Fasted Hepatically Impaired Male and Female Subjects and Fasted Matched-control Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Selpercatinib for Healthy and Hepatic Impairment. Completed, enrolled 36 participants across 7 sites.
Detailed Summary
The main purpose of this study is to assess how selpercatinib gets into the blood stream and how long it takes the body to remove it when administered to participants with impaired hepatic function compared to healthy participants. Information about safety and tolerability will be collected. The study will last up to about 7 weeks, inclusive of screening period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Hepatic Impairment
CountriesUnited States
CollaboratorsLoxo Oncology, Inc.
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartDec 2018
Primary CompletionOct 2019
Study CompletionOct 2019
First PostedJun 2022
TodayJul 2026
First PostedJun 29, 2022
Enrollment StartDec 10, 2018
Primary CompletionOct 4, 2019
Study CompletionOct 30, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.0 years ago
Interventions
Selpercatinibdrug
Administered orally.