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

NCT ID: NCT01011296

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-05-31

Brief Summary

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

Detailed Description

Phase 1 clinical trial

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Single IV Dose 1

Group Type: EXPERIMENTAL

PF-04427429

Intervention Type: DRUG

Single 0.2mg dose of intravenous infusion

Single IV Dose 2

Group Type: EXPERIMENTAL

PF-04427429

Intervention Type: DRUG

Single 1mg dose of intravenous infusion

Single IV Dose 3

Group Type: EXPERIMENTAL

PF-04427429

Intervention Type: DRUG

Single 3 mg dose of intravenous infusion

Interventions

PF-04427429

Single 0.2mg dose of intravenous infusion

Intervention Type: DRUG

PF-04427429

Single 1mg dose of intravenous infusion

Intervention Type: DRUG

PF-04427429

Single 3 mg dose of intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Pfizer, Inc.

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Phoenix, Arizona, United States

Countries

United States

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0141001&StudyName=A%20Randomized%2C%20Placebo%20Controlled%2C%20Double-Blind%2C%20Third%20Party%20Open%2C%20Parallel%20Group%2C%20First%20In%20Human%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%20And%20Pharmacodynamics%20Of%20PF-04427429%20Administered%20Intravenously%20To%20Healthy%20Adult%20Volunteers

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Other Identifiers

B0141001

Identifier Type: -

Identifier Source: org_study_id