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NCT04234672 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants
A Phase 1 study, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04234672 is a Phase 1 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 6 participants.
The verdict
NCT04234672, a Phase 1 study, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie \[μCi\]) \[14C\]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance, characterize the PK of TAK-831 in plasma and urine, and total radioactivity concentration equivalents in plasma and whole blood following a single oral suspension dose of 500 mg (approximately 100 μCi) \[14C\]TAK-831 in Period 2.
Interventions
- DRUG TAK-831 Oral Tablet
- DRUG [14C]TAK-831 IV Infusion
- DRUG [14C]TAK-831 Oral Suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-02-17 |
| Est. Completion | 2020-04-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04234672
The ClinicalTrials.gov registry entry for NCT04234672 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurocrine Biosciences, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which TAK-831 Oral Tablet is the first listed.
NCT04234672 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04234672 about?
NCT04234672 is a clinical study titled "A Study to Assess Absolute Bioavailability (ABA) of TAK-831 and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of [14C]TAK-831 in Male Healthy Participants". The purpose of this study is to determine ABA of TAK-831 following a single microdose intravenous administration of 50 microgram (μg) (approximately 1 microcurie \[μCi\]) \[14C\]TAK-831 and a single oral administration of 500 milligram (mg) TAK-831 tablets in Period 1, and to assess the mass balance...
What is the current status of trial NCT04234672?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2020-02-17. Estimated completion is 2020-04-04.
What interventions are being tested in trial NCT04234672?
The interventions under investigation include: TAK-831 Oral Tablet (DRUG), [14C]TAK-831 IV Infusion (DRUG), [14C]TAK-831 Oral Suspension (DRUG).
Who is sponsoring clinical trial NCT04234672?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
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