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NCT01414881 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects
A Phase 1 study, sponsored by Kastle Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01414881 is a Phase 1 study that has completed, run by Kastle Therapeutics. The registered enrollment target is 20 participants.
The verdict
NCT01414881, a Phase 1 study, has completed, sponsored by Kastle Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The primary objective of this Phase I exploratory study is to determine the effects of mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening Period, a 1-week Run-in Period to establish a stable diet, an approximate 11-week Treatment Period with Placebo or Mipomersen, and a 25-week Post-Treatment Follow-up Period. The total duration of any given subject's participation will be approximately 40 weeks.
Interventions
- DRUG Placebo
- DRUG mipomersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01414881
The ClinicalTrials.gov registry entry for NCT01414881 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kastle Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01414881 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01414881 about?
NCT01414881 is a clinical study titled "Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects". The primary objective of this Phase I exploratory study is to determine the effects of mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening Period, a 1-week Run-in Period to establis...
What is the current status of trial NCT01414881?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01414881?
The interventions under investigation include: Placebo (DRUG), mipomersen (DRUG).
Who is sponsoring clinical trial NCT01414881?
This trial is sponsored by Kastle Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
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