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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: SAM-760
* Drug: Placebo of SAM-760
* Drug: ketoconazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>active arm/healthy young | Drug: SAM-760<br>* SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day<br>|
| Placebo Comparator: 2<br>placebo arm | Drug: Placebo of SAM-760<br>* SAM-760 matching placebo capsule, single dose, 1 day,<br>* Other names: Placebo;|
| Other: 3<br>ketoconazole interaction evaluation | Drug: ketoconazole<br>* Ketoconazole oral tablets, 200 mg bid, 14 days<br>* Other names: ketoconazole interaction arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability. |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, tolerability, ascending single doses, healthy subjects