This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 16, 2008
Last updated: December 12, 2008
Last verified: December 2008
The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.

Condition Intervention Phase
Healthy Drug: AZD2516 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • Safety and tolerability of AZD2516 by assessment of non-serious adverse events [ Time Frame: Collected from start of residential period until last visit. ]
  • Determine the single ascending dose pharmacokinetics of AZD2516 [ Time Frame: PK sampling taken at defined timepoints during residential period ]

Estimated Enrollment: 72
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD2516 Drug: AZD2516
Solution administered once orally
Placebo Comparator: Placebo Drug: Placebo
Solution administered only once


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00754715

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

Responsible Party: Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, AstraZeneca Pharmaceuticals Identifier: NCT00754715     History of Changes
Other Study ID Numbers: D2080C00001
EudractCT: 2008-003598-42
Study First Received: September 16, 2008
Last Updated: December 12, 2008

Keywords provided by AstraZeneca:
Multiple dosing study,
safety processed this record on August 18, 2017