Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679 (SINGLE DOSE)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PF-05105679

Study type: Interventional

Funder types: Industry

Identifiers

NCT01393652

B3351001

Details and patient eligibility

About

This is a two part study. The purpose of the first part (Part A) is the evaluation of the pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The second part (Part B) of this study will focus on the exploratory pharmacodynamics of PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses selected in Part B will have been administered previously in the Part A of the study.

Enrollment: 32 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy Volunteers

Exclusion criteria

Standard Healthy Volunteers

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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32 participants in 3 patient groups

Cohort 1: Experimental intervention: PF-05105679 or placebo

Experimental group

Description:

Cohort 1

Treatment:

Drug: PF-05105679

Drug: PF-05105679

Drug: PF-05105679

Cohort 2: Experimental intervention: PF-05105679 or placebo

Experimental group

Description:

Cohort 2

Treatment:

Drug: PF-05105679

Drug: PF-05105679

Drug: PF-05105679

Cohort 3: Experimental intervention PF-05105679 or placebo and

Active Comparator group

Description:

Cohort 3

Treatment:

Drug: PF-05105679

Drug: PF-05105679

Drug: PF-05105679