NCT00972049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 4, 2010

Status Verified

March 1, 2010

Enrollment Period

3 months

First QC Date

September 3, 2009

Last Update Submit

March 2, 2010

Conditions

Healthy

Keywords

safetytolerabilityAZD2516painJapanese

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of AZD2516 in Japanese healthy subjects by assessment of adverse events, vital signs, laboratory variables and ECG

    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 Outcomes (1)

  • Investigate the single ascending dose pharmacokinetics of AZD2516 in Japanese subjects

    Blood sampling at defined timepoints during residential period and follow-up

Study Arms (2)

1

EXPERIMENTAL

Capsule administered once orally

Drug: AZD2516

2

PLACEBO COMPARATOR

Capsule administered once orally

Drug: Placebo

Interventions

AZD2516DRUG

Capsule administered once orally. Specific dose depends on dose panel.

1
PlaceboDRUG

Capsule administered once orally

2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • History of previous or ongoing somatic or psychiatric disease/condition
  • Abnormalities in ECG that may interfere with interpretation of data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Fukuoka, Japan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anders Neijber, MD, PhD

    AstraZeneca R&D Södertälje

    STUDY DIRECTOR

  • Shunji Matsuki, MD, PhD

    Kyusyu Clinical Phramacology Research Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 4, 2010

Record last verified: 2010-03

Locations

JP(1)