NCT00935662

Brief Summary

The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

2 active sites

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

July 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 13, 2010

Status Verified

September 1, 2010

Enrollment Period

1.1 years

First QC Date

July 7, 2009

Last Update Submit

September 10, 2010

Conditions

Healthy Men

Keywords

First time in manSafety studyAZD8329

Outcome Measures

Primary Outcomes (1)

  • Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)

    Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.

Secondary Outcomes (1)

  • PK samples for AZD8329

    Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose.

Study Arms (2)

AZD8329

EXPERIMENTAL

AZD8329 oral solution

Drug: AZD8329

Placebo

PLACEBO COMPARATOR

Placebo for AZD8329 oral solution

Drug: Placebo

Interventions

AZD8329DRUG

Oral solution, single ascending doses

AZD8329
PlaceboDRUG

Oral solution, placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

You may not qualify if:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Linköping, Sweden

Location

Research Site

Uppsala, Sweden

Location

MeSH Terms

Interventions

4-(4-(2-adamantylcarbamoyl)-5-tert-butyl-pyrazol-1-yl)benzoic acid

Study Officials

  • Wolfgang Kühn

    Quintiles AB, Phase I Services, Uppsala, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 9, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 13, 2010

Record last verified: 2010-09

Locations

SE(2)