Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Thrombosis
- Registration Number
- NCT00432770
- Lead Sponsor
- Archemix Corp.
- Brief Summary
The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.
- Detailed Description
The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- ≥ 18 to ≤ 65 years of age
- Weight ≤ 110 kg
- Negative qualitative urine drug/alcohol test
- Female volunteers must be of non-childbearing potential
- Male volunteers must agree to use a medically acceptable contraceptive
- Volunteers must be capable of understanding and complying with the protocol and must have signed the informed consent document
Exclusion Criteria
Any clinically significant medical disorder (e.g. diabetes, hypertension, etc.)
- Tendency to bleed easily
- History of recent trauma or surgery
- History of gout or renal stones
Clinically significant abnormal lab parameters for the following:
- PT INR > 1.4
- aPTT > reference laboratory values
- Serum creatinine > 1.3 mg/dL
- Platelet count of ≤ 100,000/mm3
- ALT/AST > 2 times ULN
- WBC ≤ 3000 x 109/L
- Hemoglobin < 11 g/dL
- Total bilirubin > 1.2 mg/dL
- CBT > 15 min
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bioanalytical Systems, Inc
🇺🇸Baltimore, Maryland, United States