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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-12-31

Brief Summary

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This is a multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of PF-05212377 (SAM-760) administered orally once a day for 14 days to healthy young adults and healthy elderly subjects. The study will be conducted under double-blind conditions (neither the investigator nor the subject will know if he/she has received PF-05212377 or a placebo). The Sponsor will know if the subject has received active treatment or a placebo.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active

Group Type EXPERIMENTAL

PF-05212377 (SAM-760)

Intervention Type DRUG

Oral capsule, once daily for 14 days 1.5 mg, 5 mg, 15 mg, 30 mg and 50 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral capsule, once daily for 14 days

Interventions

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PF-05212377 (SAM-760)

Oral capsule, once daily for 14 days 1.5 mg, 5 mg, 15 mg, 30 mg and 50 mg

Intervention Type DRUG

Placebo

Oral capsule, once daily for 14 days

Intervention Type DRUG

Other Intervention Names

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SAM-760

Eligibility Criteria

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Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes