Safety and Pharmacokinetic Study of PF-06700841 in Japanese Healthy Volunteers

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: PF-06700841

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03236493

B7931009

2017-002066-41 (EudraCT Number)

Details and patient eligibility

About

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 and pharmacodynamics of PF-06700841 after multiple oral doses of PF-06700841 in Japanese healthy volunteers.

Enrollment

8 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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.