At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Mobocertinibdrug
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.
Phase 1 Pharmacokinetics and Safety Study of Oral Mobocertinib in Subjects With Moderate or Severe Hepatic Impairment and Normal Hepatic Function
In Brief
A Phase 1 clinical trial evaluating Mobocertinib for Hepatic Impairment and Healthy Volunteers. Completed, enrolled 24 participants across 2 sites.
Detailed Summary
The purpose of this study is to characterize the single-dose plasma PK of mobocertinib and its active metabolites (AP32960 and AP32914) in participants with moderate and/or severe HI compared to matched-healthy participants with normal hepatic function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment, Healthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartOct 2020
Primary CompletionFeb 2022
Study CompletionFeb 2022
TodayJul 2026
First PostedAug 14, 2019
Enrollment StartOct 9, 2020
Primary CompletionFeb 5, 2022
Study CompletionFeb 26, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.9 years ago
Interventions
Mobocertinibdrug
Mobocertinib capsule.