A Bioavailability Study Comparing 3 Different AZD1981 Tablets

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01311635
First received: March 3, 2011
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: AZD1981, current small-particle tablet
Drug: AZD1981, new small-particle tablet
Drug: AZD1981, new large-particle table
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    • 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

  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: AZD1981, current small-particle tablet
3x100 mg per oral, single dose in fasted state
Experimental: Treatment B Drug: AZD1981, new small-particle tablet
3x100 mg per oral, single dose
Experimental: Treatment C Drug: AZD1981, new small-particle tablet
3x100 mg per oral, single dose
Experimental: Treatment D Drug: AZD1981, new large-particle table
3x100 mg per oral, single dose in fasted state

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311635

Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Wolfgang Kühn, MD Quintiles AB, Phase 1 Services
  More Information

No publications provided

Responsible Party: Christer Hultquist / MD, AstraZeneca R&D
ClinicalTrials.gov Identifier: NCT01311635     History of Changes
Other Study ID Numbers: D9830C00020
Study First Received: March 3, 2011
Last Updated: July 6, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Phase 1
bioavailability study
AZD1981
tablets
To study the relative bioavailability of single dose AZD1981 via three different tablets
To compare the bioavailability between three different AZD1981 tablets

ClinicalTrials.gov processed this record on October 23, 2014