Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers (JMAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01116011
First received: April 13, 2010
Last updated: December 14, 2010
Last verified: November 2010
  Purpose

This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.


Condition Intervention Phase
Healthy
Drug: AZD7268
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-Centre, Randomised, Double-Blind, Placebo-controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Japanese Healthy Male Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Investigate the safety and tolerability of AZD7268 by Adverse Events. [ Time Frame: From first dosing throughout the treatment period and including the follow-up period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma [ Time Frame: Blood samples will be taken from pre-dose until 48 hours post last dose ] [ Designated as safety issue: No ]
  • Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine [ Time Frame: Urine samples will be taken from post first dose until 48 hours post last dose. ] [ Designated as safety issue: No ]

Enrollment: 30
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: AZD7268 Drug: AZD7268
Capsule, Oral, BID
Placebo Comparator: Placebo Drug: Placebo
Capsule, Oral, BID

  Eligibility

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

Inclusion Criteria:

  • Provision of Informed Consent
  • Healthy male subjects, with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

  • Inability to understand or cooperate with given information
  • Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
  • History of seizure (including infant febrile seizures) or family history of seizure
  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: NCT01116011

Locations
Japan
Research Site
Kanagawa, Sagamihara, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Tomoe Fujita Kitasato University East Hospital, Kanagawa, Japan
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01116011     History of Changes
Other Study ID Numbers: D1151C00004
Study First Received: April 13, 2010
Last Updated: December 14, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I
Japanese Healthy volunteer

ClinicalTrials.gov processed this record on October 29, 2014