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

Ascending Single Dose Study Of The Safety, Tolerability And Pharmacokinetics Of SAM-760 Administered Orally To Healthy Young And Healthy Elderly Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00948662

Enrollment

124

Registered

2009-07-29

Start date

2009-09-30

Completion date

2010-12-31

Last updated

2013-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, tolerability, ascending single doses, healthy subjects

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.

Interventions

DRUGSAM-760

SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day

DRUGPlacebo of SAM-760

SAM-760 matching placebo capsule, single dose, 1 day,

DRUGketoconazole

Ketoconazole oral tablets, 200 mg bid, 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026