A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo for PF-05230907; Biological: PF-05230907

Study type: Interventional

Funder types: Industry

Identifiers

NCT01897142

2013-001387-36 (EudraCT Number)

B2341001

Details and patient eligibility

About

The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.

Enrollment: 49 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects.
• Healthy non-child bearing female subjects.
• 18 to 35 years of age.

Exclusion criteria

• Heart disease.
• Clotting disorders.
• Use of nicotine products.
• Diabetes.

Trial design

49 participants in 6 patient groups

PF-05230907 and Placebo Cohort 1

Experimental group

Treatment:

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

PF-05230907 and Placebo Cohort 2

Experimental group

Treatment:

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

PF-05230907 and Placebo Cohort 3

Experimental group

Treatment:

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

PF-05230907 and Placebo Cohort 4

Experimental group

Treatment:

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

PF-05230907 and Placebo Cohort 5

Experimental group

Treatment:

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

PF-05230907 and Placebo Cohort 6

Experimental group

Treatment:

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Drug: Placebo for PF-05230907

Biological: PF-05230907

Biological: PF-05230907

Drug: Placebo for PF-05230907