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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00754715
First received: September 16, 2008
Last updated: December 12, 2008
Last verified: December 2008
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: Yes ]
  • Determine the single ascending dose pharmacokinetics of AZD2516 [ Time Frame: PK sampling taken at defined timepoints during residential period ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00754715

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

No publications provided

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
Study First Received: September 16, 2008
Last Updated: December 12, 2008
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Multiple dosing study,
safety

ClinicalTrials.gov processed this record on September 30, 2014