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NCT03811834 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants
A Phase 1 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT03811834 is a Phase 1 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 7 participants.
The verdict
NCT03811834, a Phase 1 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study is to determine: Period 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of 50 microgram (mcg) (approximately 2 microcurie \[mcCi\]) \[14 C\]-\]-mobocertinib and single oral administration of 160 milligram (mg) mobocertinib. Period 2 (absorption, distribution, metabolism, and elimination \[ADME\]): the mass balance and metabolic profile of mobocertinib in plasma, urine, and feces, to characterize the PK of mobocertinib and its metabolites (AP32960 and AP32914) in plasma, whole blood, and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral administration of 160 mg (approximately 100 mcCi) \[14C\]-mobocertinib solution.
Interventions
- DRUG Mobocertinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-01-22 |
| Est. Completion | 2019-03-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03811834
The ClinicalTrials.gov registry entry for NCT03811834 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 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.
NCT03811834 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03811834 about?
NCT03811834 is a clinical study titled "A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants". The purpose of this study is to determine: Period 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of 50 microgram (mcg) (approximately 2 microcurie \[mcCi\]) \[14 C\]-\]-mobocertinib and single oral administration of 160 milligram (mg) mobocertinib. Period 2 (abs...
What is the current status of trial NCT03811834?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2019-01-22. Estimated completion is 2019-03-11.
What interventions are being tested in trial NCT03811834?
The interventions under investigation include: Mobocertinib (DRUG).
Who is sponsoring clinical trial NCT03811834?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
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