NCT00688831

Brief Summary

The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body (how it is taken up into the body, distributed around the body and disappears from the body

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 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

January 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2008

Completed
Last Updated

December 2, 2010

Status Verified

December 1, 2010

Enrollment Period

4 months

First QC Date

May 30, 2008

Last Update Submit

December 1, 2010

Conditions

Healthy

Keywords

AZD1305SADsafetypharmcokineticsSafety and tolerability

Outcome Measures

Primary Outcomes (1)

  • Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight

    During the study

Secondary Outcomes (1)

  • Pharmacokinetic variables

    During all dosing visits

Study Arms (2)

A

EXPERIMENTAL

AZD1305 solution for iv infusion

Drug: AZD1305

B

PLACEBO COMPARATOR

NaCl solution for iv infusion

Drug: Placebo

Interventions

AZD1305DRUG

Solution for iv infusion , single dose

A
PlaceboDRUG

NaCl solution for iv infusion, single dose

B

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • BIM 19-30 kg/m2

You may not qualify if:

  • Potassium outside normal reference values
  • ECG findings outside normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate

Study Officials

  • Helen Lunde, MD

    AstraZeneca R&D, Mölndal, Sweden

    STUDY DIRECTOR

  • Marianne Hartford, MD, PhD

    AstraZeneca, Clinical Pharmacology Unit, Sahlgrenska University Hospital, Göeborg, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 2, 2010

Record last verified: 2010-12

Locations

SE(1)