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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00972049
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : March 4, 2010
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD2516 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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
Study Start Date : September 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: 1
Capsule administered once orally
Drug: AZD2516
Capsule administered once orally. Specific dose depends on dose panel.

Placebo Comparator: 2
Capsule administered once orally
Drug: Placebo
Capsule administered once orally

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00972049

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Research Site
Fukuoka, Japan
Sponsors and Collaborators
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Study Director: Anders Neijber, MD, PhD AstraZeneca R&D Södertälje
Principal Investigator: Shunji Matsuki, MD, PhD Kyusyu Clinical Phramacology Research Clinic
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Responsible Party: AstraZeneca Identifier: NCT00972049    
Other Study ID Numbers: D2080C00004
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: March 4, 2010
Last Verified: March 2010
Keywords provided by AstraZeneca: