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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: Completed Phase 1 study, sponsored by Neurocrine Biosciences.
NCT04234672 is a Phase 1 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Bioavailability is defined as the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect. Percent absolute bioavailability, calculated for plasma TAK-831 as \[Actual Dose (IV) x AUCinf (oral)\] / \[Actual Dose (oral) x AUCinf (IV)\] x 100.
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 |
What the finished NCT04234672 record still lists
NCT04234672 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which TAK-831 Oral Tablet is the first listed.
NCT04234672 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04234672's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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