Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017.

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00799747
First received: November 26, 2008
Last updated: June 30, 2009
Last verified: June 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 ]

Enrollment: 56
Study Start Date: December 2008
Study Completion Date: April 2009
Arms Assigned Interventions
Experimental: 1
AZD4017 in ascending doses (start dose 2mg)
Drug: AZD4017
ascending single doses (start dose 2 mg), oral suspension
Placebo Comparator: 2
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

Locations
Japan
Research Site
Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Shunji Matsuki Kyusyu Clinical Phramacology Research Clinic
  More Information

No publications provided

Responsible Party: Jan Eriksson MD PhD / Medical Science Director, AstraZeneca R&D Mölndal, Sweden
ClinicalTrials.gov Identifier: NCT00799747     History of Changes
Other Study ID Numbers: D2060C00007
Study First Received: November 26, 2008
Last Updated: June 30, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
safety
tolerability
pharmacokinetics
AZD4017Japanese

ClinicalTrials.gov processed this record on April 22, 2014