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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00818129
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : July 23, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: AZD7295 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2008
Actual Study Completion Date : May 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. AE, safety laboratory test (haematology, clinical chemistry, urinalysis), 12-lead ECG, BP, pulse rate, body temperature [ Time Frame: During the study ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00818129

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Research Site
Fukuoka-City, Fukuoka, Japan
Sponsors and Collaborators
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Principal Investigator: Masatoshi Tsukamoto, MD Kyushu Clinical Pharmacolgy Reasearch Clinic
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Responsible Party: Dereck Tait, Medical Science Director, Anti-Viral EPT, Arrow Therapeutic Limited Identifier: NCT00818129    
Other Study ID Numbers: D1820C00001
First Posted: January 7, 2009    Key Record Dates
Last Update Posted: July 23, 2009
Last Verified: July 2009
Keywords provided by AstraZeneca:
Phase I
oral solution