AZD2624 Multiple Ascending Dose Study in Japan (JMAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00696865
First received: June 11, 2008
Last updated: July 15, 2009
Last verified: July 2009
  Purpose

This multiple ascending dose study will evaluate safety and tolerability after repeated ascending doses of AZD2624


Condition Intervention Phase
Healthy
Safety
Drug: AZD2624
Drug: Placebo
Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624 [ Time Frame: A single blood sample will be obtained ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2008
Study Completion Date: August 2008
Arms Assigned Interventions
Experimental: 1 Drug: AZD2624
oral suspension, 3 doses
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00696865

Locations
Japan
Research Site
Kanagawa, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Yuji Kumagai, MD, PhD Kitasato University East Hospital, Kanagawa, Japan
  More Information

No publications provided

Responsible Party: Mark A. Smith, MD, PhD - Medical Science Sr. Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00696865     History of Changes
Other Study ID Numbers: D0970C00006
Study First Received: June 11, 2008
Last Updated: July 15, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Safety
Tolerability
Phase I

ClinicalTrials.gov processed this record on July 23, 2014