Single Ascending Dose Study of SRA-444 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-06-30

Brief Summary

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This is a first-in-humans study of SRA-444. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRA-444 (SR formulation) after administration of ascending single oral doses to healthy adult subjects.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SRA-444

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy men or women of nonchildbearing potential aged 18 to 50 years,
* Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.

Exclusion Criteria

* Family history of sudden death and/or QT prolongation.
* An automatic ECG corrected QT (QTc) interval reading at screening \>450 ms and \>470 ms for male and female subjects, respectively.
* Sinus bradycardia at screening, defined as a resting heart rate ≤45 bpm. Resting supine blood pressure at screening \<110 mm Hg (systolic) and/or \<60 mm Hg (diastolic).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Netherlands, [email protected]

Locations

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Zuidlaren, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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3197A1-100

Identifier Type: -

Identifier Source: org_study_id