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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00818129
First received: December 24, 2008
Last updated: July 22, 2009
Last verified: July 2009
  Purpose

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 effect of AZD7295 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD7295 in the body.


Condition Intervention Phase
Healthy Subjects
Drug: AZD7295
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double-Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7295 Following Single and Multiple Ascending Oral Dose Administration in Healthy Male Japanese Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • AE, safety laboratory test (haematology, clinical chemistry, urinalysis), 12-lead ECG, BP, pulse rate, body temperature [ Time Frame: During the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics (Cmax, tmax, AUC, AUC0-t, CL/F, Vss/F, t1/2 , Cmin, Rac, etc) [ Time Frame: Frequent sampling until 72 hours after single administration in Single Dose Part and until 72 hours after last administration (6 days administration) in Multiple Dose Part ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: December 2008
Study Completion Date: May 2009
Arms Assigned Interventions
Experimental: 1 Drug: AZD7295
ascending single doses (start dose 90 mg), oral solution and then multiple ascending dose (tbd based on single dose results), oral solution
Placebo Comparator: 2 Drug: Placebo
multiple ascending dose (tbd based on single dose results), oral solution

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  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: NCT00818129

Locations
Japan
Research Site
Fukuoka-City, Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Masatoshi Tsukamoto, MD Kyushu Clinical Pharmacolgy Reasearch Clinic
  More Information

No publications provided

Responsible Party: Dereck Tait, Medical Science Director, Anti-Viral EPT, Arrow Therapeutic Limited
ClinicalTrials.gov Identifier: NCT00818129     History of Changes
Other Study ID Numbers: D1820C00001
Study First Received: December 24, 2008
Last Updated: July 22, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
Phase I
Japan
Japanese
oral solution

ClinicalTrials.gov processed this record on October 01, 2014