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

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: NCT00799747
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : July 2, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: AZD4017 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : December 2008
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: 1
AZD4017 in ascending doses (start dose 2mg)
Drug: AZD4017
ascending single doses (start dose 2 mg), oral suspension
Placebo Comparator: 2
Drug: Placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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).

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): NCT00799747

Research Site
Fukuoka, Japan
Sponsors and Collaborators
Principal Investigator: Shunji Matsuki Kyusyu Clinical Phramacology Research Clinic

Responsible Party: Jan Eriksson MD PhD / Medical Science Director, AstraZeneca R&D Mölndal, Sweden Identifier: NCT00799747     History of Changes
Other Study ID Numbers: D2060C00007
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs