Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD2516; Drug: Placebo

• Registration Number: NCT00754715
• Lead Sponsor: AstraZeneca

Brief Summary

The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-16
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Primary Completion: 2008-11
• Status Verified: 2008-12
• Study Completion: 2008-12
• Last Update Submitted: 2008-12-12
• Last Update Posted: 2008-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old.
• Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2

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Exclusion Criteria

• History of previous or ongoing psychiatric disease.
• Abnormalities in ECG that may interfere with interpretation of data.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD2516	AZD2516	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables	From first to last visit

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of AZD2516 by assessment of non-serious adverse events	Collected from start of residential period until last visit.
Determine the single ascending dose pharmacokinetics of AZD2516	PK sampling taken at defined timepoints during residential period

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden