Status:
COMPLETED
Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers
Lead Sponsor:
Archemix Corp.
Conditions:
Thrombosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 para...
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 para...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00432770
Start Date
December 1 2006
End Date
March 1 2007
Last Update
April 20 2007
Active Locations (1)
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1
Bioanalytical Systems, Inc
Baltimore, Maryland, United States, 21201