A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Oral Doses of AZD8566 in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic profile: concentration of AZD8566 in blood
Study Overview
Brief Summary
The purpose of this study is to determine how well tolerated and safe AZD8566 is at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Provision of written informed consent.
- •Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
- •Females who are permanently or surgically sterile or postmenopausal.
Exclusion Criteria
- •Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
- •History of any convulsions or seizures
- •History of infection or at risk of infection due to recent surgery or trauma
- •History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug
Arms & Interventions
1
Intervention: AZD8566 (Drug)
2
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic profile: concentration of AZD8566 in blood
Time Frame: Samples taken during Visit 2 (residential period) at up to 16 defined timepoints pre-dose and post- dose
Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events
Time Frame: Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events.
Secondary Outcomes
- Pharmacokinetic profile: concentration of AZD8566 in urine(Samples collected over 48 hours from pre-dose to 48 hours post-dose.)