Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT01133366
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent before any study-related procedure is performed.
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive.
* No clinically significant abnormalities based on medical history, laboratory assessments, vital sign, 12-lead electrocardiogram (ECG) results, and physical examination.
* Subjects willing and able to follow a prescribed diet.
* Subjects have not consumed nicotine or nicotine-containing products for at least 6 months before Screening.
* Subjects are nonpregnant and nonlactating, surgically sterile, postmenopausal, abstinent, or the subject or partner is willing to use a reliable method of contraception during the study and for 5 months after mipomersen dosing.
Exclusion Criteria:
* Poor metabolizer of warfarin as determined by CYP2C9 genotype testing.
* Clinically significant PT, aPTT, INR, protein C, protein S, or platelet count results or hematuria.
* Abnormal prolongation of skin bleeding time or a personal or family history of coagulation or bleeding disorders, vascular malformations including aneurysms, or venous thromboembolism.
* Active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease.
* Active malignancy of any type other than nonmelanomatous skin malignancies.
* Use of any prescribed or over-the-counter concomitant medications within 14 days before the first dose of investigational product without approval of the Investigator and Sponsor.
* Positive test result for drugs of abuse, alcohol, or cotinine or history of alcohol abuse or drug addiction.
* Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01133366
Study Brief:
Protocol Section:
NCT01133366