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

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ClinicalTrials.gov Identifier: NCT01116011
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : December 15, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: AZD7268 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2010
Primary Completion Date : July 2010
Study Completion Date : July 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: AZD7268 Drug: AZD7268
Capsule, Oral, BID
Placebo Comparator: Placebo Drug: Placebo
Capsule, Oral, BID


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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. ]

Eligibility Criteria

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
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

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): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01116011     History of Changes
Other Study ID Numbers: D1151C00004
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: December 15, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Phase I
Japanese Healthy volunteer