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NCT04056468 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04056468: Completed Phase 1 study, sponsored by Millennium Pharmaceuticals.
NCT04056468 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04056468, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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.
Interventions
- DRUG Mobocertinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-10-09 |
| Est. Completion | 2022-02-26 |
| Phase | Phase 1 |
What the finished NCT04056468 record still lists
NCT04056468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Mobocertinib is the first listed.
NCT04056468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04056468 about?
NCT04056468 is a clinical study titled "A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function". 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.
What is the current status of trial NCT04056468?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-10-09. Estimated completion is 2022-02-26.
What interventions are being tested in trial NCT04056468?
The interventions under investigation include: Mobocertinib (DRUG).
Who is sponsoring clinical trial NCT04056468?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04056468's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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