First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/17/2018
Start Date:October 17, 2017
End Date:March 22, 2018

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A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06882961 In Healthy Adult Subjects

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
single oral doses of PF-06882961 in healthy adult subjects. This is the first clinical study
of PF-06882961.


Inclusion Criteria:

- Healthy female subjects of nonchildbearing potential and/or male subjects who, at the
time of screening, are between the ages of 18 and 55 years, inclusive

- Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110
lb)

- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic,
psychiatric, neurological, or allergic disease (including drug allergies, but
excluding untreated, asymptomatic, seasonal allergies at the time of dosing.

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half lives preceding the first dose of IP (whichever is longer).

- Fertile male subjects who are unwilling or unable to use a highly effective method of
contraception for the duration of the study and for at least 28 days after the last
dose.

- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose
We found this trial at
1
site
New Haven, Connecticut 06511
?
mi
from
New Haven, CT
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