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OpenTrials
Completed

NCT Number: NCT00754715

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

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

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Key information

Conditions

Healthy

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

AZD2516

Drug

Solution administered once orally

Placebo

Drug

Solution administered only once

Primary outcomes

  1. Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables

    Time frame: From first to last visit

Secondary outcomes

  1. Safety and tolerability of AZD2516 by assessment of non-serious adverse events

    Time frame: Collected from start of residential period until last visit.

  2. Determine the single ascending dose pharmacokinetics of AZD2516

    Time frame: PK sampling taken at defined timepoints during residential period

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 in Young and Elderly Healthy Volunteers After Oral Single Ascending Doses

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 18, 2008
Registry last updated
Dec 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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