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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
History of Changes
  Purpose

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 Intervention Phase
Diabetes Mellitus Type 2
 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 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

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 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 ]

Enrollment: 107
Study Start Date: February 2009
Study Completion Date: May 2009
Arms Assigned Interventions
Experimental: 1
AZD4017 in ascending doses (start dose 75mg od)
 Drug: AZD4017
ascending multiple doses(start dose 75mg od), oral suspension
Placebo Comparator: 2
Placebo
 Drug: 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 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841048

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

No publications provided

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
Study First Received: February 10, 2009
Last Updated: September 29, 2009
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on May 23, 2013