Dose Escalation Study of PF-06741086 In Healthy Subjects

Healthy Clinical Trial

Official title:

A Randomized, Double-blind, Sponsor-open, Placebo-controlled, Single Intravenous Or Subcutaneous Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-06741086 In Healthy Subjects And An Open-label Evaluation In Healthy Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531815
• Other study ID #: B7841001
• Secondary ID: 2015-001821-17
• Status: Completed
• Phase: Phase 1
• First received: August 3, 2015
• Last updated: August 10, 2016
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• PF-06741086
PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)

Drug:
• Placebo
Placebo for PF-06741086, single dose

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs		Day 1 up to Day 84	Yes
Primary	Percentage of subjects with laboratory abnormalities		Day 1 up to Day 84	Yes
Primary	Number of subjects with change from baseline in vital signs	blood pressure, pulse rate, temperature, respiration rate	Day 1 up to Day 84	Yes
Primary	Number of subjects with change from baseline in electrocardiogram (ECG) parameters		Day 1 to Day 84	Yes
Primary	Percentage of subjects with changes from baseline in physical examination		Day 1 to Day 84	Yes
Primary	Percentage of subjects with infusion site reactions		Day 1 up to Day 7	Yes
Primary	Percentage of subjects with injection site reactions		Day 1 to Day 7	Yes
Secondary	Plasma PF-06741086 concentrations		Day 1 up to Day 84	No
Secondary	Maximum observed plasma concentration (Cmax)		Day 1 up to Day 84	No
Secondary	Time for Cmax (Tmax)		Day 1 up to Day 84	No
Secondary	Area under the curve from time zero to last quantifiable concentration (AUClast)		Day 1 up to Day 84	No
Secondary	Terminal half-life (t 1/2)		Day 1 up to Day 84	No
Secondary	Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)		Day 1 up to Day 84	No
Secondary	Volume of distribution at steady state (Vss)	Intravenous administration only	Day 1 up to Day 84	No
Secondary	Apparent volume of distribution (Vz/F)	Subcutaneous administration only	Day 1 up to Day 84	No
Secondary	Clearance (CL)	Intravenous administration only	Day 1 up to Day 84	No
Secondary	Apparent clearance (CL/F)	Subcutaneous administration only	Day 1 up to Day 84	No
Secondary	Bioavailability (F) [F = AUC (inf,sc) / AUC (inf,iv)]		Day 1 up to Day 84	No
Secondary	Mean residence time (MRT)		Day 1 up to Day 84	No
Secondary	Total tissue factor pathway inhibitor concentrations over time		Day 1 up to Day 84	No
Secondary	Thrombin generation	may include lag time, peak thrombin generation, and endogenous thrombin generation potential	Day 1 up to Day 84	No
Secondary	Prothrombin fragment 1+2 (PF1+2) concentrations over time		Day 1 up to Day 84	No
Secondary	D-dimer concentrations over time		Day 1 up to Day 84	No
Secondary	Dilute prothrombin time (dPT)		Day 1 up to Day 84	No
Secondary	Frequency of anti-drug antibody (ADA) and neutralizing antibody (NAb) production	Immunogenicity	Day 1 up to Day 84	No

External Links

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