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NCT01487460 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 137
- Enrollment target
NCT01487460: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01487460 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 137 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (128% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01487460, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 137 participants
- Enrollment target
Study Summary
This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volunteers.
Primary Outcome
Number of patients with adverse events and changes from baseline in vital signs, ECG and clinical labs (blood chemistry, hematology and urinalysis).
Interventions
- DRUG TAP311
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT01487460 record still lists
NCT01487460 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (128% higher).
The record links to 0 conditions, and to 1 intervention - of which TAP311 is the first listed.
NCT01487460 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01487460 about?
NCT01487460 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients". This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311 concentration in blood and effect of TAP311 administration on simvastatin concentration will also be assessed in healthy volun...
What is the current status of trial NCT01487460?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 137 participants. The study started on 2011-11. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01487460?
The interventions under investigation include: TAP311 (DRUG).
Who is sponsoring clinical trial NCT01487460?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01487460's enrollment target sits among peer trials
137 420th of 2000 higher than 1,579 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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