A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Biological: PF-06342674 Dose A; Biological: PF-06342674 Dose B; Biological: PF-06342674 Dose C; Biological: PF-06342674 Dose D; Biological: PF-06342674 Dose E; Biological: PF-06342674 Dose F; Biological: PF-06342674 Dose G; Biological: PF-06342674 Dose H; Biological: PF-06342674 Dose I; Biological: PF-06342674 Dose J

• Registration Number: NCT01740609
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55.
• BMI between 18.5 to 32 kg/m2.
• Total body weight ≥40 kg and ≤120 kg.

Exclusion Criteria

• Previous treatment with an antibody within 6 months prior to Day 1.
• Pregnant or nursing females; females of childbearing potential.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.0	PF-06342674 Dose D	-
2.0	PF-06342674 Dose E	-
2.0	PF-06342674 Dose F	-
2.0	PF-06342674 Dose G	-
2.0	PF-06342674 Dose H	-
2.0	PF-06342674 Dose C	-
1. Placebo	Placebo	Placebo
2.0	PF-06342674 Dose A	-
2.0	PF-06342674 Dose B	-
2.0	PF-06342674 Dose J	-
2.0	PF-06342674 Dose I	-

Primary Outcome Measures

Name	Time	Method
Causal relationship of treatment emergent AEs	60 days
Changes from baseline in safety laboratory assessments	60 days
Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters	60 days
Incidence of anti-drug-antibodies	60 days
Severity of treatment emergent AEs	60 days
Incidence of dose limiting or intolerable treatment related AEs	60 days
Incidence of treatment emergent AEs	60 days
Incidence of abnormal laboratory findings	60 days

Secondary Outcome Measures

Name	Time	Method
Area under the Concentration-Time Curve (AUC)	60 days	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)	60 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)	60 days
PK parameter estimates including T1/2.	60 days
Systemic Clearance (CL)	60 days	CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Apparent Oral Clearance (CL/F)	60 days	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Apparent Volume of Distribution (Vz/F)	60 days	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States