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Completed

NCT Number: NCT01989520

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

Study to investigate relative bioavailability of up to five different formulations of AZD5069

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Key information

Conditions

Uncontrolled and Persistent Asthma

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and/or female volunteers aged 18 to 50 years (inclusive).
  • Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening.
  • 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.
  • Healthy volunteers with neutrophil counts within the laboratory range at screening.

-

Exclusion criteria

  • 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.
  • Healthy volunteers who have previously received AZD5069.
  • 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.
  • Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to the first administration of the IP -

Treatment and study plan

Phase IIb formulation

Drug

Single oral dose 45mg AZD5069

Putative phase III formulation

Drug

Single oral dose 45mg AZD5069

Slow dissolution variant 1

Drug

Single oral dose 45mg AZD5069

Slow dissolution variant 2

Drug

Single oral dose 45mg AZD 5069

Test treatment E

Drug

Tablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2013
Registry last updated
Jun 25, 2015

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.