AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese Subjects

Study Overview
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Brief Summary
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This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male and female Japanese subjects

Official Title
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A Phase I, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Intravenous AZD9742 in Healthy Male and Female Japanese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD9742
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female (non-childbearing potential) Body mass index (BMI) : 17 to 27 kg/m 2 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 History or presence of gastrointestinal, hepatic, or renal disease or any otherHistory or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Ages Eligible for Study
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Minimum Age: 23 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose level A, B, C and optional Dose level D and E: single administration and one to three times daily for 6 days (Japanese n=8) | Drug: AZD9742<br>* IV Formulation<br>|
| Placebo Comparator: 2<br>placebo given (2 subjects in each dose group) | Drug: Placebo<br>* IV Formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry) |  | collected prior to treatment, during treatment and follow-up for a total of 18-22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the Pharmacokinetics of AZD9742 in blood and urine |  | PK-sampling during 14 pre-defined study days for PK profiling | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AZD9742, Japanese Healthy Volunteers, Phase I, Single and Multiple Ascending Dose