Status:

COMPLETED

Study to Investigate Safety, Tolerability and PK Following Single and Multiple Ascending Doses of AZD7295 in Japanese

Lead Sponsor:

AstraZeneca

Conditions:

Healthy Subjects

Eligibility:

MALE

20-55 years

Phase:

PHASE1

Brief Summary

The primary objective of this study is to investigate the safety and tolerability of single and multiple oral doses of AZD7295 in healthy male Japanese subjects. This will be done by comparing the eff...

Eligibility Criteria

Inclusion

  • Provision of signed, written and dated informed consent
  • Healthy male Japanese volunteers aged 20-55 years
  • BMI between 18 and 27 kg/m2
  • Have negative screens for HIV, hepatitis B and C viruses and syphilis

Exclusion

  • Use of prescribed medication within 2 weeks prior to the dose of study medication
  • Participation in another study that included drug treatment within 16 weeks before the start of the present study.
  • History or presence of gastrointestinal, hepatic or renal disease or a condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
  • History of severe food or drug allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged relevant by the investigator.

Key Trial Info

Start Date :

December 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2009

Estimated Enrollment :

62 Patients enrolled

Trial Details

Trial ID

NCT00818129

Start Date

December 1 2008

End Date

May 1 2009

Last Update

July 23 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Research Site

Fukuoka, Fukuoka, Japan