- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03783377
Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)
March 2, 2021 updated by: Arrowhead Pharmaceuticals
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Camperdown, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital
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Queensland
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Sippy Downs, Queensland, Australia
- University of the Sunshine Coast Clinical Trial Centre
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Western Australia
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Perth, Western Australia, Australia, 6009
- Linear Clinical Research
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Ontario
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London, Ontario, Canada, N6A 5B7
- Robarts Research Institute
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7K9
- Ecogene-21
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Montreal, Quebec, Canada, H2W 1R7
- Institute de Recherches Cliniques de Montreal
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Christchurch, New Zealand, 8011
- Lipid & Diabetes Research Group
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Auckland
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Grafton, Auckland, New Zealand, 1010
- Auckland Clinical Studies Limited
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Papatoetoe, Auckland, New Zealand, 2025
- Middlemore Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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calculated volume to match active treatment
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Experimental: ARO-APOC3
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single or multiple doses of ARO-APOC3 by subcutaneous (sc) injections
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events (AEs) Possibly or Probably Related to Treatment
Time Frame: Up to Day 113 (+/- 3 days)
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Up to Day 113 (+/- 3 days)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Single dose phase: Up to 48 hours post-dose
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PK of ARO-APOC3 in NHVs: Time to Maximum Plasma Concentration (Tmax)
Time Frame: Single dose phase: Up to 48 hours post-dose
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Single dose phase: Up to 48 hours post-dose
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PK of ARO-APOC3 in NHVs: Terminal Elimination Half-Life (t1/2)
Time Frame: Single dose phase: Up to 48 hours post-dose
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Single dose phase: Up to 48 hours post-dose
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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
|
Single dose phase: Up to 48 hours post-dose
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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
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Single dose phase: Up to 48 hours post-dose
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Reduction in Fasting Serum APOC3 from Pre-Dose Baseline
Time Frame: Up to Day 113 (+/- 3 days)
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Up to Day 113 (+/- 3 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2019
Primary Completion (Actual)
February 11, 2021
Study Completion (Actual)
February 11, 2021
Study Registration Dates
First Submitted
December 19, 2018
First Submitted That Met QC Criteria
December 19, 2018
First Posted (Actual)
December 21, 2018
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AROAPOC31001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Ionis Pharmaceuticals, Inc.RecruitingSevere HypertriglyceridemiaUnited States, South Africa, Spain, Israel, Australia, Sweden, Canada, Denmark, Hungary, Netherlands, Bulgaria, Czechia, Italy, France, Norway, New Zealand, Slovakia, Poland
Clinical Trials on ARO-APOC3
-
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Arrowhead PharmaceuticalsActive, not recruitingFamilial ChylomicronemiaKorea, Republic of, Canada, Australia, Singapore, Belgium, Spain, Japan, United States, Austria, Germany, Ireland, Oman, Poland, Israel, New Zealand, Argentina, France, Croatia, Mexico, Serbia, Turkey
-
Arrowhead PharmaceuticalsCompletedSevere HypertriglyceridemiaUnited States, Netherlands, Australia, Canada, New Zealand, Poland, Hungary, Germany
-
Arrowhead PharmaceuticalsCompletedMixed DyslipidemiaUnited States, Australia, Poland, New Zealand, Canada, Hungary
-
Visirna Therapeutics HK LimitedNot yet recruitingFamilial Chylomicronemia Syndrome
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Arrowhead PharmaceuticalsCompletedClear Cell Renal Cell CarcinomaUnited States
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Arrowhead PharmaceuticalsActive, not recruitingHomozygous Familial HypercholesterolemiaAustralia, Canada, United States, South Africa
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Arrowhead PharmaceuticalsActive, not recruitingMixed DyslipidemiaUnited States, Australia, Canada, New Zealand
-
ARO MedicalUnknownLumbar Disc Prolapse With RadiculopathyDenmark