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Multiple Ascending Dose Study To Assess Safety, Tolerability And Pharmacokinetics Of PF-05212377 (SAM-760)

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Rueil-Malmaison, , 92502 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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.
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- Inclusion Criteria for young healthy population: Healthy male and/or female subjects
of non-child bearing potential (WONCBP) between the ages of 18 and 55 years,
inclusive. (Healthy is defined as no clinically relevant abnormalities identified at
screening by a detailed medical history, full physical examination, including blood
pressure and heart rate measurement, 12-lead ECG, neurological examination and
clinical laboratory tests.)

- Inclusion Criteria for elderly population: Healthy male and/or female subjects of
non-child bearing potential between the ages of 65 and 85 years, inclusive. Subjects
must be in reasonably good health as determined by the investigator based on a
detailed medical history, full physical examination (including blood pressure and
pulse rate measurement), 12-lead ECG and clinical laboratory tests. Subjects with
mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent
diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the
investigator.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Presence or history of any disorder that may prevent the successful completion of the
study.

- Other 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.

- A score of greater than or equal to 20 on the Beck Depression Inventory and/or a
response of 1, 2, or 3 to the question related to suicide.

- History of seizure disorder and/or severe head trauma (other than a single childhood
febrile seizure).

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

- Any surgical or medical condition that may interfere with the absorption,
distribution, metabolism, or excretion of the study treatment.

- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before
study Day 1.

- History of drug abuse within 1 year before study Day 1 or a positive urine drug
screen.

- Admitted alcohol abuse or history of alcohol use that may interfere with the subject's
ability to comply with the protocol requirements.

- Consumption of more than 14 drinks/week for females or 21 drinks/week for males (1
drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL)
of hard liquor) within 6 months of screening.

- Subjects who smoke more than 10 cigarettes per day.

- Pregnant or nursing females; females of childbearing potential.

- Males who are unwilling to abstain from sexual intercourse or use a condom with all
child-bearing potential women for the duration of the study.

NCT01159496
Pfizer
Completed
Multiple Ascending Dose Study To Assess Safety, Tolerability And Pharmacokinetics Of PF-05212377 (SAM-760)

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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