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

NCT00818129 | Completed Phase 1

• 1 other identifier: D1820C00001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Phase I; Japan; Japanese; oral solution

Outcome Measures

Primary Outcomes (1)

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

  During the study

Secondary Outcomes (1)

• Pharmacokinetics (Cmax, tmax, AUC, AUC0-t, CL/F, Vss/F, t1/2 , Cmin, Rac, etc)

  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

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD7295

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD7295 DRUG

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

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Fukuoka, Fukuoka, Japan

Location

Study Officials

• Masatoshi Tsukamoto, MD

  Kyushu Clinical Pharmacolgy Reasearch Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 24, 2008
• First Posted: January 7, 2009
• Study Start: December 1, 2008
• Study Completion: May 1, 2009
• Last Updated: July 23, 2009

Record last verified: 2009-07

Locations

JP (1)