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

NCT01159496 | Completed Phase 1

• 1 other identifier: B2081003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Adverse events (spontaneous and solicited).

  0-24days

• Change from baseline in vital signs.

  0-24 days

• Change from baseline in triplicate ECGs.

  0-24 days

• Clinical safety laboratory endpoints, including a complete blood count, reticulocytes and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive.

  0-24 days

• Physical examinations and neurological examinations

  0-24 days

Secondary Outcomes (2)

• Pharmacokinetics in young adults (Plasma concentration of PF-05212377 over time (eg, AUC, Cmax, Tmax, t1/2).

  0-21 days

• Pharmacokinetics in elderly subjects (Plasma concentration of PF-05212377 over time (eg, AUC, Cmax, Tmax, t1/2).

  0-21 days

Study Arms (2)

Active

EXPERIMENTAL

Drug: PF-05212377 (SAM-760)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PF-05212377 (SAM-760) DRUG

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

Also known as: SAM-760

Active

Placebo DRUG

Oral capsule, once daily for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Rueil-Malmaison, 92502, France

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

SAM-760

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 9, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 10, 2011

Record last verified: 2011-03

Locations

FR (1)