A Phase 1, Single-centre Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Dose, Parallel-group Study to Determine the Safety, Tolerability, and Pharmacokinetics of AZD4316 in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- AstraZeneca
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Assessment of laboratory variables and physical examinations
Study Overview
Brief Summary
The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD4316 following oral administration of single and multiple doses to healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male and female subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
- •Female subjects must not be pregnant, must not be lactating and must be of non-child-bearing potential (i.e. they must be post-menopausal or surgically sterile)
- •Male subjects should be willing to use barrier contraception i.e. condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product
- •Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- •Subjects who are healthy as determined by pre study medical history, physical examination, 12-Lead ECG
Exclusion Criteria
- •History of 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 subject's ability to participate in the study.
- •Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG, including changes that may interfere with the interpretation of QTcF interval changes.
- •Current smokers, those who have smoked or used nicotine products within the previous three months.
- •History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD
- •Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (ie, during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.
Arms & Interventions
Part A: single ascending dose
AZD4316: single oral dose, with 1 group with/without food
Intervention: AZD4316 (Drug)
Part A: single ascending dose
AZD4316: single oral dose, with 1 group with/without food
Intervention: Placebo (Other)
Part B: multiple ascending dose
AZD4316: multiple oral doses
Intervention: AZD4316 (Drug)
Part B: multiple ascending dose
AZD4316: multiple oral doses
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Assessment of laboratory variables and physical examinations
Time Frame: from screening period to follow-up
Frequent assessments will be made for each subject from the screening period to follow up
Assessment of Electrocardiogram (ECG) variables
Time Frame: from screening period to follow-up
Frequent assessments will be made for each subject from the screening period to follow up
Number of participants with adverse events
Time Frame: from screening period to follow-up
Assesment of vital signs (blood pressure, pulse and temperature)
Time Frame: from screening period to follow-up
Frequent assessments will be made for each subject from the screening period to follow up
Secondary Outcomes
- Pharmacokinetic variables of AZD4316 by assessment of drug concentrations in plasma and urine(Serial blood samples and urine collection for PK evaluation throughout the period of admission and up to the time of the follow-up visit)