A Phase 1b, Randomized, Double-Blind (Sponsor Open), Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF-04447943, Co-Administered with and Without Hydroxyurea, in Subjects with Stable Sickle Cell Disease
Completed
- Conditions
- 10047066Sickle cell anemia1001890210005330
- Registration Number
- NL-OMON44079
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
Inclusion Criteria
- Stable SCD patients (Hbss or HbSB-thalasamia)
- Male/female, age 18-65, BMI 17.5-35, incl
(see protool p31)
Exclusion Criteria
- Recent Vaso occlusive crisis (<2 months)
- Severe infection (<1 month)
- Recent surgery (<3 months)
-Use of CYP3A4 inhibitors/inducers; use of PDE5 inhibitors; use of QT-prolonging medication/medication lowering seizure threshold
-History of cerebrovascular accident or seizure disorder
(see protocol p32)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety will be assessed through adverse events, changes in laboratory results,<br /><br>changes in ECG measurements, and changes in vital sign measurements</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetic endpoints will include plasma PF-04447943 AUC(0-12h), C12h,<br /><br>Cmax, and Tmax on Days 1. C1h and C2h will also be measured on Days 7 to assess<br /><br>steady-state Cmax.<br /><br><br /><br>Pharmacodynamic endpoints will include:<br /><br>Plasma cGMP<br /><br>Markers associated with cellular adhesion:<br /><br>E-selectin, P-selectin<br /><br>ICAM, VCAM<br /><br>Platelet-monocyte aggregates, platelet neutrophil aggregates<br /><br>MAC-1 expression on monocytes and neutrophils<br /><br>Markers associated with coagulation:<br /><br>Tissue Factor<br /><br>Thrombin-Antithrombin Complexes<br /><br>Prothrombin Fragments F1 + F2<br /><br>D-dimers;<br /><br>Circulating endothelial microparticles<br /><br>Hemoglobin F</p><br>
Related Research Topics
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