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

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ClinicalTrials.gov Identifier: NCT00754715
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : December 15, 2008
Information provided by:

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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 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 of AZD2516 in Young and Elderly Healthy Volunteers After Oral Single Ascending Doses
Study Start Date : September 2008
Primary Completion Date : November 2008
Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: AZD2516 Drug: AZD2516
Solution administered once orally
Placebo Comparator: Placebo Drug: Placebo
Solution administered only once

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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

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.

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 ClinicalTrials.gov identifier (NCT number): NCT00754715

Research Site
Stockholm, Sweden
Sponsors and Collaborators
Principal Investigator: Bo Fransson, MD AstraZeneca
Study Chair: Lars Ståhle, MD, PhD AstraZeneca

Responsible Party: Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00754715     History of Changes
Other Study ID Numbers: D2080C00001
EudractCT: 2008-003598-42
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: December 15, 2008
Last Verified: December 2008

Keywords provided by AstraZeneca:
Multiple dosing study,