Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers

Study Overview
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Brief Summary
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The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.

Official Title
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A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics (Including Food Effect) of Ascending Oral Doses of AZD5847 in Healthy Male Subjects and Female Subjects of Non-childbearing Potential

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD5847
* Drug: Placebo to AZD5847


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated, written informed consent prior to any study specific procedures Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG. Healthy male and female volunteers. Females must be of non childbearing potential Exclusion Criteria: Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD5847 oral suspension<br>Active | Drug: AZD5847<br>* Part A - Oral doses given to approximately 6 cohorts of 8 subjects (6 on active and 2 on placebo) on Day 1. Part B - Oral doses of AZD5847 given to 1 cohort of 8 subjects on Days 1 and 8 in either a fasted state or with a high fat meal<br>|
| Placebo Comparator: Placebo to AZD5847<br>Placebo | Drug: Placebo to AZD5847<br>* In Part A - Single oral doses of AZD5847placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals |  | Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses. |  | Samples taken during the residential period at defined timepoints pre-dose and post-dose. | 
| To assess the effect of food on the pharmacokinetics of AZD5847 following oral administration of AZD5847 |  | Samples taken during the residential period at defined timepoints pre-dose and post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteer, first time in human, food effect