Single Ascending Dose Study of SRA-444 in Healthy Subjects

Wyeth is now a wholly owned subsidiary of Pfizer64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alzheimer Disease

Interventions

SRA-444DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Unnamed facility

Zuidlaren, Netherlands

Outcomes

Primary Outcomes

Assessment of the safety and tolerability of SRA-444

Data from ClinicalTrials.gov

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