Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01090661 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects
A Phase 1 study, sponsored by Kastle Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01090661 is a Phase 1 study that has completed, run by Kastle Therapeutics. The registered enrollment target is 60 participants.
The verdict
NCT01090661, a Phase 1 study, has completed, sponsored by Kastle Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
To assess the electrocardiogram (ECG) effects of mipomersen administered as a 200-mg subcutaneous (SC) therapeutic and a 200-mg intravenous (IV; \[2-hour infusion\]) supra-therapeutic dose relative to placebo in healthy adult male and female subjects; and to evaluate the safety and pharmacokinetics (PK) of mipomersen when administered as a single therapeutic (200 mg) SC and a single, supra-therapeutic (200 mg) IV dose.
Interventions
- DRUG placebo
- DRUG mipomersen sodium
- DRUG moxifloxacin hydrochloride (Avelox®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01090661
The ClinicalTrials.gov registry entry for NCT01090661 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 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 3 interventions - of which placebo is the first listed.
NCT01090661 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01090661 about?
NCT01090661 is a clinical study titled "A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects". To assess the electrocardiogram (ECG) effects of mipomersen administered as a 200-mg subcutaneous (SC) therapeutic and a 200-mg intravenous (IV; \[2-hour infusion\]) supra-therapeutic dose relative to placebo in healthy adult male and female subjects; and to evaluate the safety and pharmacokinetics ...
What is the current status of trial NCT01090661?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2010-03. Estimated completion is 2010-05.
What interventions are being tested in trial NCT01090661?
The interventions under investigation include: placebo (DRUG), mipomersen sodium (DRUG), moxifloxacin hydrochloride (Avelox®) (DRUG).
Who is sponsoring clinical trial NCT01090661?
This trial is sponsored by Kastle Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.