Study Evaluating Safety, Tolerability, Pharmacokinetics a... | NCT00499200

Studies
Study Evaluating Safety, Tolerability, Pharmacokinetics and 5 HT1A Receptor Occupancy

NCT00499200

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Jul 9, 2008Estimated

Enrollment

42Actual

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

SRA-444

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jul 9, 2007

First Submission Date that Met QC Criteria

Jul 10, 2007

First Posted Date

Jul 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2008

Last Update Posted Date

Jul 9, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will include a preliminary pharmacokinetics (PK) / safety / tolerability evaluation in healthy elderly subjects followed by the Receptor Occupancy (RO) evaluations in healthy elderly subjects and in Alzheimer's Disease (AD) subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SRA-444 + Placebo	Experimental	Experimental; Placebo	Drug: SRA-444

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SRA-444	Drug		SRA-444 + Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the safety and tolerability of ascending single oral doses of SRA-444 in healthy elderly subjects and subjects with Alzheimer's disease		after each dose group completion
To obtain PK profiles and determine the level and duration of 5-HT1A RO of SRA-444 by PET		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Men or women from 60 years of age at screening.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion criteria:

History of drug abuse within 1 year before study day 1.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director
Trial Manager	For Sweden: MedInfoNord@wyeth.com	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Uppsala		753 23	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided