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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 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 24 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04056468
The ClinicalTrials.gov registry entry for NCT04056468 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Millennium Pharmaceuticals, which has 135 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mobocertinib is the first listed.
NCT04056468 reports 0 study locations.
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.
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