Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

Archemix

Status and phase: Completed; Phase 1

Conditions: Thrombosis

Treatments: Drug: ARC1779

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432770

1779-06-001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind