Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017. - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00799747

Purpose

The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to Japanese healthy male volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.

Condition	Intervention	Phase
Healthy	Drug: AZD4017 Drug: Placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Single Group Assignment, Safety Study
Official Title:	A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study in Healthy Japanese Male Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD4017 After Single Ascending Oral Doses

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables [ Time Frame: The variables will be measure predose and the repeatedly during the following 47 hours after dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F) [ Time Frame: Blood samples for determination of AZD4017 concentartion will be taken predose and repeatedly during the 47 hours post dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	64
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD4017 in ascending doses (start dose 2mg)	Drug: AZD4017 ascending single doses (start dose 2 mg), oral suspension
2: Placebo Comparator Placebo	Drug: Placebo placebo

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Provision of signed written and dated informed consent
BMI between 19 and 27 kg/m2
Subjects must be willing to use barrier methods of contraception

Exclusion Criteria:

History of any clinical significant disease
Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Laboratory blood sample result showing elevated liverenzymes (ASAT, ALAT) and muscle enzymes (CK).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799747

Contacts

Contact: AstraZeneca Japan Clinical Study, Information

+81-6-6453-8011

Locations

Japan
Research Site
Fukuoka, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Shunji Matsuki

Kyusyu Clinical Phramacology Research Clinic

More Information

Responsible Party:	AstraZeneca R&D Mölndal, Sweden ( Jan Eriksson MD PhD / Medical Science Director )
Study ID Numbers:	D2060C00007
Study First Received:	November 26, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00799747
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

safety
tolerability
pharmacokinetics
AZD4017Japanese

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009