Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Liposomal siRNA in Subjects With High Cholesterol
This study has been terminated.
(Potential for immune stimulation to interfere with further dose escalation.)
Sponsor:
Tekmira Pharmaceuticals Corporation
Information provided by:
Tekmira Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00927459
First received: June 23, 2009
Last updated: January 21, 2010
Last verified: January 2010
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Purpose
This study is a Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study in male and female subjects with high cholesterol. A maximum of 32 subjects is planned for enrollment in this study.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: PRO-040201 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO-040201 in Male and Female Subjects With Hypercholesterolemia |
Resource links provided by NLM:
Further study details as provided by Tekmira Pharmaceuticals Corporation:
Primary Outcome Measures:
- Safety and tolerability of PRO-040201 [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics of PRO-040201 in Humans [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Pharmacodynamics of PRO-040201 in Humans [ Time Frame: 29 days ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | June 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PRO-040201
PRO-040201 with placebo control in each cohort
|
Drug: PRO-040201
Single dose IV infusion
|
|
Placebo Comparator: Placebo
PRO-040201 with placebo control in each cohort
|
Drug: Placebo
placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Fasting, stable LDL-C ≥ 160 mg/dL
- Fasting, stable triglyceride < 400 mg/dL
- BMI between 22 and 35 kg/m2, inclusive
- Females must be of non-child bearing potential
- Males of reproductive potential must agree to practice effective contraception throughout the study and for 3 months following infusion
Exclusion Criteria:
- Clinically significant endocrine, hematologic, renal, hepatic, pulmonary, uncontrolled psychiatric, or neurologic disease
- Cancer within 5 years prior to screening
- History of congestive heart failure or chronic heart failure
- Uncontrolled cardiac arrhythmias
- History of coronary heart disease
- Clinically significant abnormal baseline ECG
- History of additional risk factors for torsades de pointes
- Hepatitis B, C, or HIV positive
- Current diagnosis or known history of liver disease
- A marked baseline prolongation of QT/QTc interval
- Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or a creatine phosphokinase (CPK) >3 x upper limit of normal (ULN) at screening
- Alanine aminotransferase, AST, GGT, or total bilirubin >2 x ULN at screening
- Serum creatinine > 1.5 mg/dL
- Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on 2 occasions during screening
- Concomitant use of medications that prolongs the QT/QTc interval
- Treatment with lipid lowering therapy within 30 days prior to screening
- Use of investigational drug within 3 months prior to screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927459
Locations
| United States, Ohio | |
| Medpace Clinical Pharmacology Unit | |
| Cincinnati, Ohio, United States, 45212 | |
Sponsors and Collaborators
Tekmira Pharmaceuticals Corporation
Investigators
| Principal Investigator: | Douglas Logan, MD | Medpace Clinical Pharmacology Unit |
More Information
No publications provided
| Responsible Party: | Mark Murray, PhD, CEO, Tekmira Pharmaceuticals Corporation |
| ClinicalTrials.gov Identifier: | NCT00927459 History of Changes |
| Other Study ID Numbers: | TKM-ApoB-001 |
| Study First Received: | June 23, 2009 |
| Last Updated: | January 21, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Tekmira Pharmaceuticals Corporation:
|
cholesterol coronary artery disease |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013