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NCT02201056 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT02201056: Completed Phase 1 study, sponsored by Takeda.
NCT02201056 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02201056, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.
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 Placebo
- DRUG TAK-935
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-07 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT02201056 record still lists
NCT02201056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02201056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02201056 about?
NCT02201056 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935". The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.
What is the current status of trial NCT02201056?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2014-07. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02201056?
The interventions under investigation include: Placebo (DRUG), TAK-935 (DRUG).
Who is sponsoring clinical trial NCT02201056?
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 NCT02201056's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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