First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PF-04427429

Study type: Interventional

Funder types: Industry

Identifiers

NCT01011296

B0141001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.

Full description

Phase 1 clinical trial

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects between the ages of 18 and 50 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of between 50 kg and 100 kg inclusive.
• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Willing and able to comply with the requirement for using the recommended highly effective contraceptive methods throughout the study.

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• History of febrile illness within 5 days prior to the first dose.
• A positive urine drug screen

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Single IV Dose 1

Experimental group

Treatment:

Drug: PF-04427429

Drug: PF-04427429

Drug: PF-04427429

Single IV Dose 2

Experimental group

Treatment:

Drug: PF-04427429

Drug: PF-04427429

Drug: PF-04427429

Single IV Dose 3

Experimental group

Treatment:

Drug: PF-04427429

Drug: PF-04427429

Drug: PF-04427429