Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: SAM-760; Drug: Placebo of SAM-760; Drug: ketoconazole

• Registration Number: NCT00948662
• Lead Sponsor: Pfizer

Brief Summary

This study will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and to evaluate the effects of concomitant administration of ketoconazole on the safety and the concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-28
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Study Start: 2009-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Men or women of non-childbearing potential aged 18 to 50 years inclusive (healthy young subjects) and > 65 years (healthy elderly subjects) at screening.
• Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight >= 50 kg.

Exclusion Criteria

• Presence or history of any disorder that may prevent the successful completion of the study.
• Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational drug or placebo.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SAM-760	active arm/healthy young
2	Placebo of SAM-760	placebo arm
3	ketoconazole	ketoconazole interaction evaluation

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability.	5 days

Secondary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax) for PF-05212377 over time.	5 days
Measurement of Area Under the curve (AUC) for PF-05212377.	5 days
Time of maximum (Tmax) concentration of PF-05212377 in plasma.	5 days
Elimination half life (t1/2) of PF-05212377.	5 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Rueil Malmaison, France