At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 36 enrolled
Drug / intervention
Pirtobrutinibdrug
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.
An Open-label, Nonrandomized, Single-dose, Parallel-group, Safety, Tolerance, and Pharmacokinetic Study of LOXO-305 Administered to Fasted Hepatically Impaired Male and Female Subjects and Fasted Matched-control Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Pirtobrutinib for Healthy and Hepatic Insufficiency. Completed, enrolled 36 participants across 8 sites.
Detailed Summary
The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function and healthy participants. The side effects and tolerability of pirtobrutinib will also be evaluated. Participation could last about 46 days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Hepatic Insufficiency
CountriesUnited States
CollaboratorsLoxo Oncology, Inc.
Timeline
Phase 1CompletedFinished
202120222023202420252026
Enrollment StartDec 2020
Primary CompletionDec 2021
First PostedJan 2024
TodayJul 2026
First PostedJan 5, 2024
Enrollment StartDec 18, 2020
Primary CompletionDec 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 2.5 years ago
Interventions
Pirtobrutinibdrug
Administered orally