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Completed

NCT Number: NCT01311635

A Bioavailability Study Comparing 3 Different AZD1981 Tablets

The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.

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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

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive
  • Have a body mass index between 19-30 kg/m2 and weigh at least 50 kg and no more than 100 kg, inclusive
  • Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening
  • Volunteers must be willing to use barrier methods of contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods.

Exclusion criteria

  • Any clinically significant disease or disorder
  • Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2
  • Prolonged QTcF >450 ms or shortened QTcF<340 ms at Visit 1 or family history of long QT syndrome
  • History of, or current alcohol or drug abuse

Treatment and study plan

AZD1981, current small-particle tablet

Drug

3x100 mg per oral, single dose in fasted state

AZD1981, new small-particle tablet

Drug

3x100 mg per oral, single dose

AZD1981, new large-particle table

Drug

3x100 mg per oral, single dose in fasted state

Primary outcomes

  1. Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981

    Time frame: Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period.

Secondary outcomes

  1. To evaluate basic systemic PK parameters as follows:

    Time frame: PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period

    • AUC(0-t): area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration
    • tmax: time to reach Cmax
    • t1/2λz: terminal half-life
    • CL/F: apparent plasma clearance
    • MRT: apparent mean residence time
    • Vz/F: apparent volume of distribution during terminal phase

  2. To evaluate the safety and tolerability of AZD1981 by assessment of adverse events, laboratory safety parameters, vital signs, ECG, physical examination and weight

    Time frame: Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Open Label, Randomised, 4-way Crossover Study to Investigate the Relative Bioavailability of Single Dose AZD1981 Via 3 Different Tablets in Healthy Men and Healthy Women of Non-childbearing Potential

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 9, 2011
Registry last updated
Jul 7, 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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