AZD2624 Multiple Ascending Dose Study in Japan (JMAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00696865
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : July 16, 2009
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Brief Summary:
This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624

Condition or disease Intervention/treatment Phase
Healthy Safety Drug: AZD2624 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2624 When Given in Multiple Ascending Oral Doses in Young Healthy Male Japanese Subjects
Study Start Date : May 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Experimental: 1 Drug: AZD2624
oral suspension, 3 doses

Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. To assess the safety and tolerability of multiple ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs [ Time Frame: All assessments are made at each visit, at least daily, during the study. ]

Secondary Outcome Measures :
  1. To evaluate and characterize the pharmacokinetics of AZD2624 and its metabolites when given orally in multiple ascending doses of AZD2624 to young healthy male Japanese subjects by assessment of drug concentration in plasma [ Time Frame: Blood samples will be taken before and after study drug administration. ]
  2. Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624 [ Time Frame: A single blood sample will be obtained ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy young male Japanese volunteers

Exclusion Criteria:

  • Significant illness, as judged by the investigator, within 2 weeks of screening visit or Day 1
  • Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit or Day 1
  • Blood loss in excess of 200 mL within 30 days of screening visit or Day 1, in excess of 400 mL within 90 days of screening visit or Day 1, or in excess of 1200 mL within 1 year of screening visit or Day 1
  • Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator at screening or pre first dose

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 identifier (NCT number): NCT00696865

Research Site
Kanagawa, Japan
Sponsors and Collaborators
Principal Investigator: Yuji Kumagai, MD, PhD Kitasato University East Hospital, Kanagawa, Japan

Responsible Party: Mark A. Smith, MD, PhD - Medical Science Sr. Director, AstraZeneca Pharmaceuticals Identifier: NCT00696865     History of Changes
Other Study ID Numbers: D0970C00006
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: July 16, 2009
Last Verified: July 2009

Keywords provided by AstraZeneca:
Phase I