NCT00689039

Brief Summary

The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how the medication is metabolised by the body (how it is taken up, distributed, and how it disappears from the body). The study is performed in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Apr 2007

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.2 years 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

1.3 years

First QC Date

May 30, 2008

Last Update Submit

December 1, 2010

Conditions

Healthy

Keywords

AZD1305safetypharmacokineticsmultiple ascending dosesSafety and pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Adverse events, ECG, 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 ER tablet

Drug: AZD1305

B

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Interventions

AZD1305DRUG

ER tablet, administered as single and repeated doses.

A
PlaceboDRUG

Tablet, administered as single and repeated doses.

B

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
  • Clinically normal physical findings, laboratory values and resting ECG as judged by the investigator

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Gothenburg, 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 at Sahlgrenska University Hospital, 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

April 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

December 3, 2010

Record last verified: 2010-12

Locations

SE(1)