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Completed

NCT Number: NCT00972049

Study to Assess Safety, Tolerability and Pharmacokinetics After Single Dose of AZD2516 to Japanese Healthy Subjects

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

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Key information

Conditions

Healthy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Weight between 45 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2
  • Japanese males aged between 20 to 45 years old (young) and Japanese males or females aged between 65 to 80 years old (elderly)

Exclusion criteria

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

Treatment and study plan

AZD2516

Drug

Capsule administered once orally. Specific dose depends on dose panel.

Placebo

Drug

Capsule administered once orally

Primary outcomes

  1. Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG

    Time frame: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 3 and follow up visit 3

Secondary outcomes

  1. Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects

    Time frame: Blood sampling at defined timepoints during residential period and follow-up

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 After Oral Single Ascending Doses of AZD2516 in Young and Elderly Japanese Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 4, 2009
Registry last updated
Mar 4, 2010

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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