NCT00879346

Brief Summary

Phase I, randomised, open label, 3-period crossover study in healthy male subjects to investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the safety and tolerability of AZD8931.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Mar 2009

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

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 23, 2009

Status Verified

October 1, 2009

First QC Date

April 7, 2009

Last Update Submit

October 22, 2009

Conditions

Healthy

Keywords

Healthy VolunteersADMEHealthy male volunteers

Outcome Measures

Primary Outcomes (1)

  • To investigate the effect of food on the pharmacokinetics of AZD8931 160mg oral dose

    Multiple blood PK samples taken between predose to up to 5 days post last dose

Secondary Outcomes (1)

  • To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG

    Maximus of 7 weeks (From time of consent to last visit including any follow-up)

Study Arms (1)

1

EXPERIMENTAL

160mg oral dose of AZD8931

Drug: AZD8931

Interventions

AZD8931DRUG

160mg oral single dose (4 x 40mg tablets)

1

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of written informed consent
  • Body mass index (BMI) between 19 and 30 kg/m2

You may not qualify if:

  • Use of any prescribed or non-prescribed medication (including analgesics, herbal remedies, vitamins and minerals) during the two weeks prior to the first administration of investigational product
  • Administration of another investigational medicinal product in the 3 months before the start of dosing in this study
  • Definite or suspected clinically relevant personal history of adverse drug reactions, or drug hypersensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Alderley Park, Cheshire, United Kingdom

Location

MeSH Terms

Interventions

AZD 8931

Study Officials

  • Emeline Ramos, MD

    AstraZeneca, Clinical Pharamcology Unit, Alderley Park

    PRINCIPAL INVESTIGATOR

  • Mary Stuart, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 10, 2009

Study Start

March 1, 2009

Study Completion

July 1, 2009

Last Updated

October 23, 2009

Record last verified: 2009-10

Locations

GB(1)