Status:
COMPLETED
Safety and Pharmacokinetic Study of PF-06700841 in Japanese Healthy Volunteers
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study is a phase 1 study of PF-06700841. PF-06700841 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics ...
Eligibility Criteria
Inclusion
- Subject must have four Japanese grandparents who were born in Japan.
- Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
- BMI of 17.5 to 27.5 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.
Exclusion
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
- 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 :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03236493
Start Date
August 16 2017
End Date
October 12 2017
Last Update
October 25 2017
Active Locations (1)
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1
Pfizer Clinical Research Unit
Brussels, Belgium, B-1070