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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00972049
First received: September 3, 2009
Last updated: March 2, 2010
Last verified: March 2010
  Purpose

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects [ Time Frame: Blood sampling at defined timepoints during residential period and follow-up ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.
  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: NCT00972049

Locations
Japan
Research Site
Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Anders Neijber, MD, PhD AstraZeneca R&D Södertälje
Principal Investigator: Shunji Matsuki, MD, PhD Kyusyu Clinical Phramacology Research Clinic
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00972049     History of Changes
Other Study ID Numbers: D2080C00004
Study First Received: September 3, 2009
Last Updated: March 2, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
safety
tolerability
AZD2516
pain
Japanese

ClinicalTrials.gov processed this record on September 30, 2014