We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00841048
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : September 30, 2009
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: AZD4017 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 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 Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses
Study Start Date : February 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
AZD4017 in ascending doses (start dose 75mg od)
Drug: AZD4017
ascending multiple doses(start dose 75mg od), 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 measured predose and then repeatedly during the study ]

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 concentration will be taken predose and repeatedly during the study. ]
  2. Laboratory screen to evaluate effect on metabolic variables [ Time Frame: Blood samples will be taken pre-dose and repeatedly during the study ]
  3. Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues [ Time Frame: Baseline and repeatedly after treatment ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 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 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).

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 ClinicalTrials.gov identifier (NCT number): NCT00841048

Research Site
Gothenburg, Sweden
Sponsors and Collaborators
Principal Investigator: Marianne Hartford, MD PhD AstraZeneca Clinical Pharmacolgy Unit Sahlgrenska University Hospital SE-413 45 Göteborg Sweden

Responsible Party: Jan Eriksson MD PhD / Medical Science Director, AstraZeneca R&D Mölndal, Sweden
ClinicalTrials.gov Identifier: NCT00841048     History of Changes
Other Study ID Numbers: D2060C00002
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: September 30, 2009
Last Verified: September 2009

Keywords provided by AstraZeneca:
Safety and tolerability

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs