drugset / Trial / NCT04056468

A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function

NCT04056468

Phase 1 Completed 24 enrolled Millennium Pharmaceuticals, Inc.
Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2020-10-09
Primary completion
2022-02-05
Completion
2022-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Mobocertinib Small molecule 40 mg Oral

Indications

No indication recorded.