NCT00754715

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2008

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, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 15, 2008

Status Verified

December 1, 2008

Enrollment Period

2 months

First QC Date

September 16, 2008

Last Update Submit

December 12, 2008

Conditions

Healthy

Keywords

Multiple dosing study,safety

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables

    From first to last visit

Secondary Outcomes (2)

  • Safety and tolerability of AZD2516 by assessment of non-serious adverse events

    Collected from start of residential period until last visit.

  • Determine the single ascending dose pharmacokinetics of AZD2516

    PK sampling taken at defined timepoints during residential period

Study Arms (2)

AZD2516

EXPERIMENTAL
Drug: AZD2516

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD2516DRUG

Solution administered once orally

AZD2516
PlaceboDRUG

Solution administered only once

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Stockholm, Sweden

Location

Study Officials

  • Bo Fransson, MD

    AstraZeneca

    PRINCIPAL INVESTIGATOR

  • Lars Ståhle, MD, PhD

    AstraZeneca

    STUDY CHAIR

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 16, 2008

First Posted

September 18, 2008

Study Start

September 1, 2008

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

December 15, 2008

Record last verified: 2008-12

Locations

SE(1)