Uncontrolled and Persistent Asthma
Conditions
Keywords
Relative bioavailability, Healthy volunteers, Neutrophils
Brief summary
Study to investigate relative bioavailability of up to five different formulations of AZD5069
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
Interventions
DRUGPhase IIb formulation
Single oral dose 45mg AZD5069
DRUGPutative phase III formulation
Single oral dose 45mg AZD5069
DRUGSlow dissolution variant 1
Single oral dose 45mg AZD5069
DRUGSlow dissolution variant 2
Single oral dose 45mg AZD 5069
DRUGTest treatment E
Tablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 |
| 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) | 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 |
| Description of pharmacokinetics of AZD5069 and its metabolite in terms of terminal half-life (t½λz), time to reach maximum plasma concentration (tmax) | 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 |
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 |
| Description of effect on neutrophils in terms of the mean of ANC ratio values calculated baseline to 24 hours post dose (ANCmean,ratio) | 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 |
| 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) | 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 |
Countries
United Kingdom
Outcome results
None listed