High Lipoprotein(a) MedDRA version: 18.1 Level: PT Classification code 10054009 Term: Lipoprotein (a) increased System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Code: ISIS 494372
Pharmaceutical Form: Solution for injection
Current Sponsor code: ISIS 494372
Other descriptive name: ISIS 494372
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
Ionis Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Males or females aged 18-75 inclusive • Females non-pregnant and non-lactating, surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) post-menopausal (defined as 12 months of spontaneous amenorrhea in females > 55 years of age or, in females = 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and FSH levels in the postmenopausal range for the laboratory involved), abstinent, or if engaged in sexual relations of child-bearing potential, subject is using an acceptable contraceptive method (refer to Section 6.3.1) from the time of signing the informed consent form until at least 16 weeks after the last dose of Study Drug • Males must be surgically sterile, abstinent or if engaged in sexual relations with a female of child-bearing potential, the patient must be using an acceptable contraceptive method from the time of signing the informed consent form until at least 16 weeks after the last dose of Study Drug • BMI =40 kg/m2 • Lipoprotein(a) =125 and =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Clinically significant abnormalities in medical history (e.g., documented previous myocardial infarction, PCI, or major surgery within 3 months of screening, planned surgery that would occur during the study) or physical examination at screening • Clinically significant abnormalities in screening laboratory values that would render a patient unsuitable for inclusion, including the following: a. Urine protein/creatinine (P/C) ratio = 0.2 mg/mg. In the event of a P/C ratio above this threshold, eligibility may be confirmed by a quantitative total urine protein measurement of 1.5 x ULN d. Bilirubin, > ULN. Patients with Gilbert’s syndrome (elevated indirect bilirubin with normal direct bilirubin and normal ALT and AST) may be eligible after discussion with the Medical Monitor e. Alkaline phosphatase, serum creatinine or BUN > ULN f. Platelet count 499 mL within 8 weeks of screening • Have any other conditions, which, in the opinion of the Investigator would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the safety and tolerability of ISIS 494372 in individual patients at escalating doses of 100, 200, and 300 mg/week To characterize the efficacy of ISIS 494372 in lowering Lp(a) using a dose titration study design ;Secondary Objective: None;Primary end point(s): To characterize the safety and tolerability of ISIS 494372 in individual patients at doses of 100, 200, and 300 mg/week To characterize the efficacy of ISIS 494372 in lowering Lp(a) using a dose titration study design;Timepoint(s) of evaluation of this end point: LPLV - Day 190 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none | — |
Countries
Canada, Denmark, Germany, Netherlands, United Kingdom
Contacts
Public ContactTeresa Brandt
Ionis Pharmaceticals, Inc.
Outcome results
None listed