A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients
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A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients On the Web |
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Official Title
A phase 2a, multi-center, randomized, double-blind, placebo-controlled, single ascending dose study to investigate the safety, tolerability and pharmacokinetics of a single intravenous infusion of CSL112 in patients with stable atherothrombotic disease
Objective
To determine the safety, tolerability and pharmacokinetics of a single ascending dose of intravenous infusion of CSL-112 in patients with stable atherothrombotic disease.
Sponsor
CSL Limited
Timeline
| Timeline | |
| Start Date | February 2012 |
| End Date | December 2012 |
| Status | Completed |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01499420.
Study Description
| Study Description | |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | |
| Allocation | Randomized |
| Endpoint | Safety study |
| Interventional Model | Parallel assignment |
| Masking | Double Blind |
| Study Details | |
| Primary Purpose | Prevention |
| Condition | Stable atherothrombotic disease |
| Intervention | CSL112 (single escalating intravenous doses) |
| Study Arms | CSL112 (reconstituted high density lipoprotein) Placebo (single intravenous doses of normal saline 0.9%) |
| Population Size | 45 |
The previous information was derived from ClinicalTrials.gov on 09/19/2013 using the identification number NCT01499420.
Eligibility Criteria
Inclusion Criteria
- Male or female aged 18 years to 80 years
- Subjects must have documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization
- Subjects on a stable medication regimen
- Body weight 50 kg or greater at screening
Exclusion Criteria
- Moderate/severe heart failure or renal impairment
- Uncontrolled hyperglycemia in subjects with type 1 or type 2 diabetes
- Receipt of the combination of omeprazole and clopidogrel within 1 month of randomization
- Subjects whose medical history, condition or medication regimen may interfere with the evaluation of the safety and tolerability of CSL112 (for example significantly altered electrocardiogram (ECG) waveform, hepatobiliary disease, malignancy, thrombocytopenia, etc.)
- Known hypersensitivity to the product components
Outcomes
Primary Outcomes
- Safety
- Time Frame: 14 days
- Designated as safety issue: Yes
- Clinically significant elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- Time Frame: 14 days
- Designated as safety issue: Yes
Secondary Outcomes
- Pharmacokinetic profile of apolipoprotein A-I (apoA-I)
- Time Frame: 9 days
- Designated as safety issue: No
- Plasma apoA-I area under the curve (AUC)
- Time Frame: 9 days
- Designated as safety issue: No
- Plasma apoA-I Cmax
- Time Frame: 9 days
- Designated as safety issue: No
- Plasma apoA-I Tmax
- Time Frame: 9 days
- Designated as safety issue: No
Publications
Results
Pending
Conclusion
Pending