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Completed

NCT Number: NCT00818129

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

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.

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Key information

Conditions

Healthy Subjects

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD7295

Drug

ascending single doses (start dose 90 mg), oral solution and then multiple ascending dose (tbd based on single dose results), oral solution

Placebo

Drug

multiple ascending dose (tbd based on single dose results), oral solution

Primary outcomes

  1. AE, safety laboratory test (haematology, clinical chemistry, urinalysis), 12-lead ECG, BP, pulse rate, body temperature

    Time frame: During the study

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Study completion
2009
First posted
Jan 7, 2009
Registry last updated
Jul 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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