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: Completed Phase 1 study, sponsored by Kastle Therapeutics.

NCT01090661 is a Phase 1 study that has completed, run by Kastle Therapeutics. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 60 participants
Start Date 2010-03
Est. Completion 2010-05
Phase Phase 1
Kastle Therapeutics

13 total trials

What the finished NCT01090661 record still lists

NCT01090661 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT01090661 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01090661's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00576069 · 60 participants

    Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma

  • NCT01297400 · 60 participants · Phase 2

    Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns

  • NCT01734122 · 60 participants

    Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor

  • NCT01804634 · 60 participants · Phase 2

    Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01090661, the US trial registry maintained by the National Library of Medicine. NCT01090661 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.