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Completed

NCT Number: NCT01330758

A Study to Compare Two Different Tablet Formulations of AZD8931 in Healthy Males and Females

A study to compare two different tablet formulations of AZD8931 in healthy males and females.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects aged 18 to 55 years
  • Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child bearing potential
  • Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg
  • Male subjects must be willing to use barrier methods of contraception
  • Be willing and able to comply with study procedures, restrictions and requirements

Exclusion criteria

  • History of any clinically significant disease or disorder
  • Any clinically significant abnormalities at screening
  • Use of any prescribed or non-prescribed medication within 2 weeks
  • Receipt of another NCE or participation in any other clinical trial within 3 months
  • Subjects who have previously received AZD8931

Treatment and study plan

AZD8931

Drug

40 mg AZD8931 wet granulation tablet formulation

Primary outcomes

  1. To determine the relative bioavailability of 40 mg AZD8931 Phase II wet granulation tablet formulation in relation to the 40mg AZD8931 Phase II/III roller compacted tablet formulation.

    Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Secondary outcomes

  1. To further investigate the safety and tolerability variables (adverse events,vital signs, ECG, physical examination, safety labs).

    Time frame: From screening period through to 5 to 10 days after visit 3. An average time of 7 weeks.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomised, Open-label, Cross-over, Single-centre Study in Healthy Male and Non-fertile Female Volunteers to Determine the Relative Bioavailability of the Phase II Wet Granulation Tablet Formulation Compared to the Phase II/III Roller Compacted Tablet Formulation of AZD8931

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 7, 2011
Registry last updated
Jul 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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