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SAM-760

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 25, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment124

FDA Designations

No designations recorded

Clinical trial landscape

SAM-760 · 1 trial · 1 indication

Phase 1 1
NCT00948662Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy SubjectsHealthy
COMPLETED124 Analytics
PHASE1COMPLETED
Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALactive arm/healthy young
2PLACEBO_COMPARATORplacebo arm
3OTHERketoconazole interaction evaluation

Interventions

NameTypeDescription
SAM-760DRUGSAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day
Placebo of SAM-760DRUGSAM-760 matching placebo capsule, single dose, 1 day,
ketoconazoleDRUGKetoconazole oral tablets, 200 mg bid, 14 days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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 hist...

Countries:France
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Frequently asked questions about SAM-760

What is SAM-760?

SAM-760 is an investigational small molecule being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other. It is not approved and remains under clinical investigation.

What does SAM-760 target?

The molecular target of SAM-760 has not been disclosed in available information. Therefore, its mechanism of action is not specified. The drug is being studied for its safety and tolerability in healthy subjects, but the specific biological target is not publicly detailed.

Who makes SAM-760?

SAM-760 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is responsible for the clinical development of this investigational small molecule drug.

What phase is SAM-760 in?

SAM-760 is in Phase 1 clinical development. A Phase 1 study evaluating the safety and tolerability of single oral doses of SAM-760 in healthy subjects has been completed. The drug is investigational and has not received regulatory approval.

What clinical trials is SAM-760 in?

SAM-760 has one completed clinical trial, identified as NCT00948662. This Phase 1 study evaluated the safety and tolerability of single oral doses of SAM-760 in healthy subjects. The trial was conducted in France, enrolled 124 participants, and was randomized, double-blind, and placebo-controlled.

Is SAM-760 the same as any other drug?

No alternative names for SAM-760 have been identified in available information. The drug is known only by its code name SAM-760 in clinical trial records. It is not associated with any other marketed or investigational drug name.