Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volu… (NCT02709850) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS ANGPTL3-LRx in Healthy Volunteers With Elevated Triglycerides and Participants With Familial Hypercholesterolemia
Canada48 participantsStarted 2015-11-30
Plain-language summary
The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS ANGPTL3-LRx (ISIS 703802) given to healthy volunteer subjects with elevated triglycerides and subjects with familial hypercholesterolemia.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for All Cohorts:
* Must have given written informed consent and be able to comply with all study requirements
* Males or females 18 to 65 years, inclusive, at the time of informed consent
* Body Mass Index (BMI) ≤ 35.0 kg/m2
* Females must be non-pregnant and non-lactating, and either surgically sterile or postmenopausal.
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
Inclusion criteria for Cohorts, A, D, and AA to DD only:
* Fasting triglycerides (TG) ≥ 150 mg/dL at Screening
* Fasting low density lipoprotein cholesterol (LDL-C) \> 70 mg/dL at Screening
Inclusion criteria for Cohorts B and C only:
* Fasting TG 90 - 150 mg/dL at Screening
* Fasting LDL-C \> 70 mg/dL at Screening
Inclusion Criteria for Cohort EE Only:
* Homozygous FH diagnosis and fasting LDL-C ≥ 190 mg/dL (4.9 mmol/L)
Inclusion Criteria for Cohort FF Only:
* Heterozygous FH diagnosis and fasting LDL-C ≥ 160 mg/dL (4.1 mmol/L)
Inclusion Criteria for Cohorts EE and FF Only:
* Maximally tolerated stable LDL-C lowering agents (stable for at least 12 weeks)
* On stable low-fat diet
* Stable weight (± 4 kg) for ≥ 6 weeks prior to screening
Exclusion Criteria for All Cohorts:
* Known history or positive test for Human Immunodeficiency Virus (HIV), Hepatitis C (HCV), or Hepatitis B (HBV)
* Treatment with another Study Drug, biological agent, or device within one-month or 5-half-lives of screening
* Regular use of alcohol within 6 months of scr…
What they're measuring
1
Safety and tolerability of single and multiple doses of IONIS ANGPTL3-LRx (incidence, severity, and dose-relationship of adverse effects and changes in the laboratory parameters)
Timeframe: Up to Day 127
2
Pharmacokinetics after single and multiple doses of IONIS ANGPTL3-LRx.
Timeframe: Up to Day 127
3
Pharmacodynamics of IONIS ANGPTL3-LRx (Changes in serum ANGPTL3 levels)