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NCT03224325 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy Participants
A Phase 1 study of Healthy, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT03224325: Completed Phase 1 study of Healthy, sponsored by Neurocrine Biosciences.
NCT03224325 is a Phase 1 study of Healthy that has completed, run by Neurocrine Biosciences. The registered enrollment target is 50 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03224325, a Phase 1 study of Healthy, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and tolerability of TAK-831 when administered as multiple oral doses at escalating dose levels in healthy participants.
Primary Outcome
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that oc
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAK-831 Tablet T2
- DRUG TAK-831 Suspension
Study Locations (1)
California
- California Clinical Trials Medical Group/PAREXEL - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-07-21 |
| Est. Completion | 2018-09-09 |
| Phase | Phase 1 |
What the finished NCT03224325 record still lists
NCT03224325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03224325 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03224325 about?
NCT03224325 is a clinical study titled "A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy Participants". The purpose of this study is to evaluate the safety and tolerability of TAK-831 when administered as multiple oral doses at escalating dose levels in healthy participants.
What is the current status of trial NCT03224325?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2017-07-21. Estimated completion is 2018-09-09.
What conditions does trial NCT03224325 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03224325?
The interventions under investigation include: Placebo (DRUG), TAK-831 Tablet T2 (DRUG), TAK-831 Suspension (DRUG).
Who is sponsoring clinical trial NCT03224325?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03224325 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03224325's enrollment target sits among peer trials
50 448th of 1090 higher than 618 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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