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

NCT01159496 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-03-10

No results posted yet for this study

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

Interventions

DRUG

PF-05212377 (SAM-760)

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

DRUG

Placebo

Oral capsule, once daily for 14 days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01159496 on ClinicalTrials.gov