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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01114152
First received: April 28, 2010
Last updated: August 2, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Healthy
Drug: AZD9742
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize the Pharmacokinetics of AZD9742 in blood and urine [ Time Frame: PK-sampling during 14 pre-defined study days for PK profiling ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   23 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01114152     History of Changes
Other Study ID Numbers: D2690C00003
Study First Received: April 28, 2010
Last Updated: August 2, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014