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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01114152
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 11.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD9742; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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; IV Formulation
Placebo Comparator: 2 placebo given (2 subjects in each dose group)	Drug: Placebo; IV Formulation

Outcome Measures

Primary Outcome Measures

1. 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

1. Characterize the Pharmacokinetics of AZD9742 in blood and urine [PK-sampling during 14 pre-defined study days for PK profiling]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Glendale	California	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Principal Investigator: Mark Yen, M..D., California Clinical Trials
• Study Director: David Melnick, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01114152
• Other Study ID Numbers: D2690C00003
• First Posted: Apr 30, 2010
• Last Update Posted: Aug 3, 2010
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: AZD9742; Japanese Healthy Volunteers; Phase I; Single and Multiple Ascending Dose

Study Results

No Results Posted as of Aug 3, 2010