A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01090661
- Run by
- Kastle Therapeutics, LLC
- People needed
- 60
- Starts
- 2010-03-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2016-08-03
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Written informed consent provided before any study-related procedures are performed.
- Body mass index (BMI) of 19 to 32 kg/m2 inclusive.
- Subjects can not have consumed nicotine or nicotine-containing products for at least 6 months before Screening.
- Subjects are nonpregnant and nonlactating, surgically sterile, postmenopausal, abstinent, or subject or partner is willing to use a reliable method of contraception during the study and 5 months after the last dose of investigational product.
You may not qualify if…
- History of risk factors for Torsades de Pointes, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments or family history of Long QT or Brugada Syndrome.
- Abnormal screening ECG that is interpreted by the Investigator to be clinically significant.
- Use of concomitant medications (prescribed or over-the-counter), without the approval of the Investigator and Sponsor, within 7 days before the first dose of investigational product.
- Clinically significant abnormal findings on the physical examination, ECG, blood pressure, heart rate, medical history, or clinical laboratory results at Screening or before dosing.
- History of clinically significant allergies or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- Positive test for HIV antibody, hepatitis C antibody, or hepatitis B surface antigen.
- Positive test for drugs of abuse, alcohol, or cotinine at Screening or before dosing or history of drug or alcohol abuse or dependence within 1 year before Screening.
- History of cancer, with the exception of basal cell carcinoma.
Where it is running
- PPD Development, LP — Austin, Texas, United States
Full record on ClinicalTrials.gov
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