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NCT02389881 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy Participants
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT02389881: Completed Phase 1 study, sponsored by Takeda.
NCT02389881 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02389881, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of TAK-058 in healthy non-elderly and elderly 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 (eg, 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 treatment-emergent adverse event (TEAE) is defined
Interventions
- DRUG TAK-058
- DRUG TAK-058 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT02389881 record still lists
NCT02389881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which TAK-058 is the first listed.
NCT02389881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02389881 about?
NCT02389881 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy Participants". The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of TAK-058 in healthy non-elderly and elderly participants.
What is the current status of trial NCT02389881?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2015-02. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02389881?
The interventions under investigation include: TAK-058 (DRUG), TAK-058 Placebo (DRUG).
Who is sponsoring clinical trial NCT02389881?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02389881's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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