Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00791752
First received: November 12, 2008
Last updated: June 15, 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 healthy 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 Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase 1Study in Healthy Volunteers to Assess the Safety, Tolerability andPharmacokinetics 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, laboratoryvariables [ 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 concenration will be taken predose and repeatedly during the 47 hours post dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2008
Study Completion Date: March 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:   18 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 30 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791752

Locations
Sweden
Research Site
Gotteborg, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Marianne Hartford, MD PhD Sahlgrenska University Sweden
  More Information

No publications provided

Responsible Party: Jan Eriksson MD PhD / Medical Science Director, AstraZeneca R&D Mölndal, Sweden
ClinicalTrials.gov Identifier: NCT00791752     History of Changes
Other Study ID Numbers: D2060C00001
Study First Received: November 12, 2008
Last Updated: June 15, 2009
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Safety and Tolerability

ClinicalTrials.gov processed this record on September 29, 2014