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Trial record 16 of 16 for:    AZD 5069

Study to Investigate Relative Bioavailability of up to Five Different Formulations of AZD5069

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ClinicalTrials.gov Identifier: NCT01989520
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
Study to investigate relative bioavailability of up to five different formulations of AZD5069

Condition or disease Intervention/treatment Phase
Uncontrolled and Persistent Asthma Drug: Phase IIb formulation Drug: Putative phase III formulation Drug: Slow dissolution variant 1 Drug: Slow dissolution variant 2 Drug: Test treatment E Phase 1

Detailed Description:
An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers
Study Start Date : January 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: Treatment A
Phase IIb formulation
Drug: Phase IIb formulation
Single oral dose 45mg AZD5069

Experimental: Treatment B
Putative phase III formulation
Drug: Putative phase III formulation
Single oral dose 45mg AZD5069

Experimental: Treatment C
Slow dissolution variant 1
Drug: Slow dissolution variant 1
Single oral dose 45mg AZD5069

Experimental: Treatment D
Slow dissolution variant 2
Drug: Slow dissolution variant 2
Single oral dose 45mg AZD 5069

Experimental: Treatment E
Optional treatment that may use one of 3 45 mg (intermediate dissolution variant) of AZD5069
Drug: Test treatment E
Tablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069




Primary Outcome Measures :
  1. Description of pharmacokinetics of AZD5069 and its metabolite in terms of area under plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration and extrapolated to infinity (AUC(0-last) and AUC) [ Time Frame: Samples taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose ]
    Curve taken during each of the 5 treatments

  2. Description of pharmacokinetics of AZD5069 and its metabolite in terms of observed maximum plasma concentration (Cmax), plasma concentration measured at 12 hours (C12h), Cmax/C12h ratio, Cmax/AUC ratio, terminal rate constant (λz) [ Time Frame: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose ]
    Curve taken during each of the 5 treatments

  3. Description of pharmacokinetics of AZD5069 and its metabolite in terms of terminal half-life (t½λz), time to reach maximum plasma concentration (tmax) [ Time Frame: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose ]
    Curve taken during each of the 5 treatments

  4. Description of pharmacokinetics of AZD5069 and its metabolite in terms of apparent systemic clearance (CL/F) (AZD5069 only), and apparent volume of distribution (Vz/F) (AZD5069 only) [ Time Frame: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose ]
    Curve taken during each of the 5 treatments


Secondary Outcome Measures :
  1. Description of effect on neutrophils in terms of circulating neutrophil numbers reported as absolute circulating neutrophil counts (ANC). The minimum absolute neutrophil count (ANCmin) and the time to ANCmin (ANCtmin) [ Time Frame: Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    Samples taken during each of the 5 treatments

  2. Description of effect on neutrophils in terms of mean of ANC values from predose to 24 hours postdose (ANCmean), the minimum of the ANC ratio values (ANCmin,ratio) [ Time Frame: Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    Samples taken during each of the 5 treatments

  3. Description of effect on neutrophils in terms of the mean of ANC ratio values calculated baseline to 24 hours post dose (ANCmean,ratio) [ Time Frame: Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose ]
    Samples taken during each of the 5 treatments



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and/or female volunteers aged 18 to 50 years (inclusive).
  2. Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening.
  3. Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum (min) weight 50 kg and maximum (max) weight 100 kg.
  4. Healthy volunteers with neutrophil counts within the laboratory range at screening.

    -

Exclusion Criteria:

  1. A definite or suspected personal history of severe allergy, intolerance or hypersensitivity or ongoing allergy to drugs with a similar chemical structure or class to AZD5069 and/or the excipients, as judged to be clinically relevant by the Investigator.
  2. Healthy volunteers who have previously received AZD5069.
  3. Volunteers with latent tuberculosis as suggested by their history and judged by the Investigator; confirmatory testing with eg, Quantiferon(R) -TB Gold may be done if required.
  4. Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to the first administration of the IP -

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): NCT01989520


Locations
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United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Olufeyikemi Oluwayi, MD Quintiles London UK
Study Director: Bengt Larssons, MD Astrazeneca Mölndal, Sweden

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01989520     History of Changes
Other Study ID Numbers: D3551C00002
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by AstraZeneca:
Relative bioavailability, Healthy volunteers, Neutrophils