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Trial record 1 of 1 for:    NCT03783377
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Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)

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ClinicalTrials.gov Identifier: NCT03783377
Recruitment Status : Completed
First Posted : December 21, 2018
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple doses of ARO-APOC3 in healthy adult volunteers and in patients with severe hypertriglyceridemia and familial chylomicronemia syndrome (FCS).

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Familial Chylomicronemia Drug: ARO-APOC3 Drug: sterile normal saline (0.9% NaCl) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of ARO-APOC3 in Adult Healthy Volunteers as Well as in Severely Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome
Actual Study Start Date : March 8, 2019
Actual Primary Completion Date : February 11, 2021
Actual Study Completion Date : February 11, 2021


Arm Intervention/treatment
Experimental: ARO-APOC3 Drug: ARO-APOC3
single or multiple doses of ARO-APOC3 by subcutaneous (sc) injections

Placebo Comparator: Placebo Drug: sterile normal saline (0.9% NaCl)
calculated volume to match active treatment




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment [ Time Frame: Up to Day 113 (+/- 3 days) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of ARO-APOC3 in Normal Healthy Volunteers (NHVs): Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Single dose phase: Up to 48 hours post-dose ]
  2. PK of ARO-APOC3 in NHVs: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Single dose phase: Up to 48 hours post-dose ]
  3. PK of ARO-APOC3 in NHVs: Terminal Elimination Half-Life (t1/2) [ Time Frame: Single dose phase: Up to 48 hours post-dose ]
  4. PK of ARO-APOC3 in NHVs: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) [ Time Frame: Single dose phase: Up to 48 hours post-dose ]
  5. PK of ARO-APOC3 in NHVs: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) [ Time Frame: Single dose phase: Up to 48 hours post-dose ]
  6. Reduction in Fasting Serum APOC3 from Pre-Dose Baseline [ Time Frame: Up to Day 113 (+/- 3 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
  • Willing to provide written informed consent and to comply with study requirements
  • Normal electrocardiogram (ECG) at screening
  • Hypertriglyceridemic patients must have a history of fasting serum triglycerides of at least 300 mg/dL (3.38 mmol/L) at screening or verifiable diagnosis of FCS

Exclusion Criteria:

  • Clinically significant health concerns
  • Regular use of alcohol within one month prior to Screening
  • Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
  • Recent use of illicit drugs
  • Use of more than two tobacco/nicotine containing or cannabis products per month within 6 months prior to drug administration (applicable only to Normal Healthy Volunteers)

Note: additional inclusion/exclusion criteria may apply, per protocol


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783377


Locations
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Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
University of the Sunshine Coast Clinical Trial Centre
Sippy Downs, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
Linear Clinical Research
Perth, Western Australia, Australia, 6009
Canada, Ontario
Robarts Research Institute
London, Ontario, Canada, N6A 5B7
Canada, Quebec
Ecogene-21
Chicoutimi, Quebec, Canada, G7H 7K9
Institute de Recherches Cliniques de Montreal
Montreal, Quebec, Canada, H2W 1R7
New Zealand
Auckland Clinical Studies Limited
Grafton, Auckland, New Zealand, 1010
Middlemore Hospital
Papatoetoe, Auckland, New Zealand, 2025
Lipid & Diabetes Research Group
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Arrowhead Pharmaceuticals
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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03783377    
Other Study ID Numbers: AROAPOC31001
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type I
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias