Assessment of the Safety and Pharmacokinetics of Single and Multiple Oral Doses of AZD4316 in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: AZD4316
* Drug: AZD4316
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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 AZD4316. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Part A: single ascending dose<br>AZD4316: single oral dose, with 1 group with/without food | Drug: AZD4316<br>* Single oral doses of AZD4316 suspension in the fasted state. In one group in Part A, subjects will receive a second dose of AZD4316 in the fed state (within 30 min after receiving a high fat breakfast)<br>Other: Placebo<br>* Placebo to match AZD4316<br>|
| Placebo Comparator: Part B: multiple ascending dose<br>AZD4316: multiple oral doses | Drug: AZD4316<br>* Multiple oral doses of AZD4316 suspension. It's planned that doses will be administered in the fasted state, however, if in Part A it's shown that food increases absorption of AZD4316, then doses will be administered after a meal.<br>Other: Placebo<br>* Placebo to match AZD4316<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | from screening period to follow-up | 
| Assesment of vital signs (blood pressure, pulse and temperature) | Frequent assessments will be made for each subject from the screening period to follow up | from screening period to follow-up | 
| Assessment of laboratory variables and physical examinations | Frequent assessments will be made for each subject from the screening period to follow up | from screening period to follow-up | 
| Assessment of Electrocardiogram (ECG) variables | Frequent assessments will be made for each subject from the screening period to follow up | from screening period to follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers, safety, tolerability