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

Phase 1CompletedNCT01989520

AstraZeneca36 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Uncontrolled and Persistent Asthma

Interventions

Phase IIb formulationDRUG

Single oral dose 45mg AZD5069

Putative phase III formulationDRUG

Single oral dose 45mg AZD5069

Slow dissolution variant 1DRUG

Single oral dose 45mg AZD5069

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 -

Locations (1)

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

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)

Curve taken during each of the 5 treatments

Time frame: Samples taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

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)

Curve taken during each of the 5 treatments

Time frame: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

Description of pharmacokinetics of AZD5069 and its metabolite in terms of terminal half-life (t½λz), time to reach maximum plasma concentration (tmax)

Curve taken during each of the 5 treatments

Time frame: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

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)

Curve taken during each of the 5 treatments

Time frame: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose

Secondary Outcomes

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)

Samples taken during each of the 5 treatments

Time frame: Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose

Data from ClinicalTrials.gov

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