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NCT01299805 · ClinicalTrials.gov registry record · Phase 1
Effects of Vortioxetine (Lu AA21004) on the Concentrations of Selected Neurotransmitters in Healthy Male Adults
A Phase 1 study of Healthy, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT01299805: Completed Phase 1 study of Healthy, sponsored by Takeda.
NCT01299805 is a Phase 1 study of Healthy that has completed, run by Takeda. The registered enrollment target is 17 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01299805, a Phase 1 study of Healthy, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the body), the pharmacokinetics (the body's handling of the drug), and the safety and tolerability of vortioxetine, once daily (QD) in healthy men.
Primary Outcome
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC\[0-24\]) of the neurotransmitter 5-HT (serotonin) in plasma was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vortioxetine
Study Locations (1)
California
- - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT01299805 record still lists
NCT01299805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01299805 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01299805 about?
NCT01299805 is a clinical study titled "Effects of Vortioxetine (Lu AA21004) on the Concentrations of Selected Neurotransmitters in Healthy Male Adults". The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the body), the pharmacokinetics (the body's handling of the drug), and the safety and tolerability of vortioxetine, once daily (QD) in healthy men.
What is the current status of trial NCT01299805?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2011-03. Estimated completion is 2011-07.
What conditions does trial NCT01299805 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01299805?
The interventions under investigation include: Placebo (DRUG), Vortioxetine (DRUG).
Who is sponsoring clinical trial NCT01299805?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01299805 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 NCT01299805's enrollment target sits among peer trials
17 929th of 1090 higher than 156 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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