NCT00689403

Brief Summary

To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2008

Typical duration for phase_1 healthy

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

February 1, 2008

Completed
4 months 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
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

Enrollment Period

5 months

First QC Date

May 30, 2008

Last Update Submit

December 1, 2010

Conditions

Healthy

Keywords

AZD1305pharmacokineticsProperties of different ER formulations

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic variables

    During all dosing visits

Secondary Outcomes (1)

  • Adverse events, ECG, safety laboratory, vital signs, physical examination

    During the study

Study Arms (2)

Part A: 2x2 crossover

EXPERIMENTAL

4 different AZD1305 ER formulations

Drug: AZD1305

Part B: 3x3 crossover

EXPERIMENTAL

2 different AZD1305 ER formulations and a reference formulation

Drug: AZD1305

Interventions

AZD1305DRUG

Extended release capsules, oral single doses

Part A: 2x2 crossover

Eligibility Criteria

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

You may qualify if:

  • Healthy male between the age of 20 - 45
  • Non-smoking

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

Harrow, United Kingdom

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

  • Daniel Bradford, MD, MA, MBBS, DCPSA

    PAREXEL Clinical Pharmacology Research UnitHarrow, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 3, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

GB(1)