Dose Escalation Study of PF-06741086 In Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: PF-06741086Drug: Placebo
- Registration Number
- NCT02531815
- Lead Sponsor
- Pfizer
- Brief Summary
This Phase 1 first-in-human single ascending dose study will be a randomized, double-blind, placebo-controlled investigation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06741086.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 41
Inclusion Criteria
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and 100 kg (220 lbs).
Exclusion Criteria
- Increased risk of thrombosis (coronary artery disease, hypercholesterolemia, diabetes)
- Use of nicotine/tobacco products
- Clotting disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 3 (SC) PF-06741086, Placebo PF-06741086 - Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo PF-06741086 - Cohort 1 (subcutaneous [SC]) PF-06741086, Placebo Placebo - Cohort 2 (SC) PF-06741086, Placebo PF-06741086 - Cohort 2 (SC) PF-06741086, Placebo Placebo - Cohort 3 (SC) PF-06741086, Placebo Placebo - Cohort 4 (Intravenous [IV]) PF-06741086, Placebo PF-06741086 - Cohort 4 (Intravenous [IV]) PF-06741086, Placebo Placebo - Cohort 5 (IV) PF-06741086, Placebo PF-06741086 - Cohort 5 (IV) PF-06741086, Placebo Placebo - Cohort 6 (IV) PF-06741086, Placebo PF-06741086 - Cohort 6 (IV) PF-06741086, Placebo Placebo - Cohort 7 (IV) PF-06741086, Placebo PF-06741086 - Cohort 7 (IV) PF-06741086, Placebo Placebo - Cohort 8 (subcutaneous [SC]) PF-06741086 PF-06741086 -
- Primary Outcome Measures
Name Time Method Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs Day 1 up to Day 84 Percentage of subjects with laboratory abnormalities Day 1 up to Day 84 Number of subjects with change from baseline in vital signs Day 1 up to Day 84 blood pressure, pulse rate, temperature, respiration rate
Number of subjects with change from baseline in electrocardiogram (ECG) parameters Day 1 to Day 84 Percentage of subjects with changes from baseline in physical examination Day 1 to Day 84 Percentage of subjects with infusion site reactions Day 1 up to Day 7 Percentage of subjects with injection site reactions Day 1 to Day 7
- Secondary Outcome Measures
Name Time Method Plasma PF-06741086 concentrations Day 1 up to Day 84 Maximum observed plasma concentration (Cmax) Day 1 up to Day 84 Time for Cmax (Tmax) Day 1 up to Day 84 Area under the curve from time zero to last quantifiable concentration (AUClast) Day 1 up to Day 84 Terminal half-life (t 1/2) Day 1 up to Day 84 Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) Day 1 up to Day 84 Volume of distribution at steady state (Vss) Day 1 up to Day 84 Intravenous administration only
Apparent volume of distribution (Vz/F) Day 1 up to Day 84 Subcutaneous administration only
Clearance (CL) Day 1 up to Day 84 Intravenous administration only
Apparent clearance (CL/F) Day 1 up to Day 84 Subcutaneous administration only
Bioavailability (F) [F = AUC (inf,sc) / AUC (inf,iv)] Day 1 up to Day 84 Mean residence time (MRT) Day 1 up to Day 84 Total tissue factor pathway inhibitor concentrations over time Day 1 up to Day 84 Thrombin generation Day 1 up to Day 84 may include lag time, peak thrombin generation, and endogenous thrombin generation potential
Prothrombin fragment 1+2 (PF1+2) concentrations over time Day 1 up to Day 84 D-dimer concentrations over time Day 1 up to Day 84 Dilute prothrombin time (dPT) Day 1 up to Day 84 Frequency of anti-drug antibody (ADA) and neutralizing antibody (NAb) production Day 1 up to Day 84 Immunogenicity
Trial Locations
- Locations (1)
Pfizer Clinical Research Unit
🇧🇪Brussels, Belgium