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A Bioavailability Study Comparing 3 Different AZD1981 Tablets

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ClinicalTrials.gov Identifier: NCT01311635
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : July 7, 2011
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311635


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

Responsible Party: Christer Hultquist / MD, AstraZeneca R&D
ClinicalTrials.gov Identifier: NCT01311635     History of Changes
Other Study ID Numbers: D9830C00020
First Posted: March 9, 2011    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011

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