Status:
COMPLETED
Safety and Pharmacokinetic Study of PF-06651600 in Healthy Volunteers
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is a first in human study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test single and multiple doses of PF-06651600. The goal...
Eligibility Criteria
Inclusion
- Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
- BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
- Evidence of personally signed and dated informed consent document.
- Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
- Subjects must avoid high intensity UV light exposure (eg, active sunbathing, tanning beds/booths or sunlamps) from the first dose of study drug and for the duration of the study.
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
- History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
- Screening blood pressure \>140/90 mm Hg.
- Screening laboratory abnormalities as defined by the protocol.
- Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02309827
Start Date
December 1 2014
End Date
April 1 2016
Last Update
September 19 2016
Active Locations (1)
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1
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070