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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD9742; Drug: Placebo

• Registration Number: NCT01114152
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-29
• Study First Posted: 2010-04-30
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-02
• Last Update Posted: 2010-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD9742	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)
2	Placebo	placebo given (2 subjects in each dose group)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Characterize the Pharmacokinetics of AZD9742 in blood and urine	PK-sampling during 14 pre-defined study days for PK profiling

Trial Locations

Locations (1)

Research Site; 🇺🇸 Glendale, California, United States