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Clinical Trial In Healthy Volunteers And Health Elderly Volunteers To Evaluate The Safety, Tolerability And Blood Concentration After Single And Multiple Escalating Oral Doses Of PF-06751979.

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy female subjects of non childbearing potential and male subjects.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 (32 kg/m2 for healthy elderly); and a
total body weight >50 kg (110 lbs) at Screening.

- 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 study.

- Additional criterion for subjects of Japanese descent who may be enrolled in Part B
(multiple ascending dose cohorts in healthy subjects): Japanese subjects who have four
Japanese grandparents born in Japan.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

- Male subjects with partners currently pregnant; male subjects able to father children
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.

- Unwilling or unable to comply with the Lifestyle Guidelines described in the protocol.

- Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of
the study.

- Any severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or investigational
product administration or may interfere with the interpretation of study results and,
in the judgment of the Investigator, would make the subject inappropriate for entry
into this study.

NCT02793232
Pfizer
Completed
Clinical Trial In Healthy Volunteers And Health Elderly Volunteers To Evaluate The Safety, Tolerability And Blood Concentration After Single And Multiple Escalating Oral Doses Of PF-06751979.

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