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Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses (MAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00841048
First received: February 10, 2009
Last updated: September 29, 2009
Last verified: September 2009

February 10, 2009
September 29, 2009
February 2009
Not Provided
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables [ Time Frame: The variables will be measured predose and then repeatedly during the study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00841048 on ClinicalTrials.gov Archive Site
  • 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 concentration will be taken predose and repeatedly during the study. ] [ Designated as safety issue: Yes ]
  • Laboratory screen to evaluate effect on metabolic variables [ Time Frame: Blood samples will be taken pre-dose and repeatedly during the study ] [ Designated as safety issue: Yes ]
  • Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues [ Time Frame: Baseline and repeatedly after treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses
A Randomised, Single-blind, Placebo-controlled, Single Centre, Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses

The primary aim of this study is to investigate the safety and tolerability of AZD4017 when given as multiple oral ascending doses to healthy volunteers. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected and some measures of pharmacokinetics versus pharmacodynamics will be included. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Diabetes Mellitus Type 2
  • Drug: AZD4017
    ascending multiple doses(start dose 75mg od), oral suspension
  • Drug: Placebo
  • Experimental: 1
    AZD4017 in ascending doses (start dose 75mg od)
    Intervention: Drug: AZD4017
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
May 2009
Not Provided

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 clinically 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 liver enzymes (ASAT, ALAT) and muscle enzymes (CK).
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00841048
D2060C00002
No
Jan Eriksson MD PhD / Medical Science Director, AstraZeneca R&D Mölndal, Sweden
AstraZeneca
Not Provided
Principal Investigator: Marianne Hartford, MD PhD AstraZeneca Clinical Pharmacolgy Unit Sahlgrenska University Hospital SE-413 45 Göteborg Sweden
AstraZeneca
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP