Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017

• ClinicalTrials.gov Identifier: NCT00791752
• Recruitment Status: Completed
• First Posted: November 14, 2008
• Last Update Posted: June 16, 2009
• Sponsor: AstraZeneca
• Information provided by: AstraZeneca

Tracking Information

• First Submitted Date: November 12, 2008
• First Posted Date: November 14, 2008
• Last Update Posted Date: June 16, 2009
• Study Start Date: November 2008
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: November 13, 2008): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 13, 2008): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017
• 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
• 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 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Participant)
• Condition: Healthy

Intervention

• Drug: AZD4017
  ascending single doses (start dose 2 mg), oral suspension
• Drug: Placebo
  Placebo

Study Arms

• Experimental: 1
  AZD4017 in ascending doses (start dose 2mg)
  Intervention: Drug: AZD4017
• Placebo Comparator: 2
  Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: November 13, 2008): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2009
• Primary Completion Date: Not Provided

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT00791752
• Other Study ID Numbers: D2060C00001
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jan Eriksson MD PhD / Medical Science Director, AstraZeneca R&D Mölndal, Sweden
• Study Sponsor: AstraZeneca
• Collaborators: Not Provided

Investigators

• Principal Investigator: Marianne Hartford, MD PhD; Sahlgrenska University Sweden

• PRS Account: AstraZeneca
• Verification Date: June 2009