Healthy
Conditions
Keywords
Healthy volunteer, Single ascending dose, Safety, Tolerability, Healthy volunteer study
Brief summary
The purpose of this study is to determine how well tolerated and safe AZD5069 is at different dose levels in healthy male and/or females. The study will also investigate how quickly AZD5069 is absorbed into and cleared by the body.
Interventions
DRUGAZD5069
Single dose of oral solution.
DRUGPlacebo
Single dose of oral solution.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of signed and dated, written informed consent * Healthy male or female (of non child bearing potential) caucasian subjects aged 18 to 65 years with suitable veins for cannulation or repeated venepuncture * Body mass index of between 18 and 30 kg/m2 inclusive
Exclusion criteria
* Subjects must not have any clinically significant disease or disorder, which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subjects ability to participate in the study * Subjects must not have any history of gastrointestinal, liver or kidney disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body * Subjects must not have had any significant illness or medical/surgical procedures or injuries with 4 weeks of administration of the investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of AZD5069 assessing vitals signs (blood pressure, pulse rate,body temperature), ECG,laboratory variables (including high sensitivity C-reactive protein, circulating neutrophils), continuous cardiac monitoring using telemetry. | Baselines assessments at Visit 1 (enrolment). Assessments pre-dose at Visit 2 and at protocol defined time-points post-dose. Follow up assessments at Visit 3. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile: concentration of AZD5069 in blood | Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose. |
| Measurement of the effect of AZD5069 on circulating neutrophils | Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose. |
| Pharmacodynamic profile: assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood | Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose. |
Countries
United Kingdom
Outcome results
None listed