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

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ClinicalTrials.gov Identifier: NCT01114152
Recruitment Status : Completed
First Posted : April 30, 2010
Last Update Posted : August 3, 2010
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD9742 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
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 : April 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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




Primary Outcome Measures :
  1. Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry) [ Time Frame: 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 [ Time Frame: PK-sampling during 14 pre-defined study days for PK profiling ]


Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114152


Locations
United States, California
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

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01114152     History of Changes
Other Study ID Numbers: D2690C00003
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: August 3, 2010
Last Verified: August 2010

Keywords provided by AstraZeneca:
AZD9742
Japanese Healthy Volunteers
Phase I
Single and Multiple Ascending Dose