First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 12/6/2018 |
Start Date: | December 2009 |
End Date: | May 2010 |
A Randomized, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group, First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.
pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.
Phase 1 clinical trial
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
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