To Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01083212
First received: March 8, 2010
Last updated: June 30, 2010
Last verified: June 2010
  Purpose

The purpose of this study is to evaluate the effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: AZD1656
Drug: Gemfibrozil
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open, Placebo Controlled, Two-way Crossover Phase I Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC and Cmax. [ Time Frame: Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PK of AZD1656 when administered with placebo or following repeated dosing of germfibrozil by assessment of AUC0-t, tmax, t1/2, CL/F and Vz/F [ Time Frame: Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration. ] [ Designated as safety issue: No ]
  • PK of AZD1656 metabolite, when AZD1656 is administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC, AUC0-t, Cmax, tmax, t1/2 [ Time Frame: Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration. ] [ Designated as safety issue: No ]
  • Safety of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables including 24-h plasma glucose, physical examination and adverse events [ Time Frame: Paper ECG, BP/pulse preentry, pre-dose,day 4, period 1 and 2, and follow-up on day +7-10 days. Weight, physical examination preentry and pre-dose (period 1 and 2), follow-up. 7-point plasma-glucose on pre-entry, day 3 and 5, period 1 and 2. ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Gemfibrozil day 1-5 + AZD1656 day 4, 1 week without, Placebo day 1-5 + AZD1656 day 4
Drug: AZD1656
Single dose,oral tablet
Drug: Gemfibrozil
Oral tablet bid on day 1 - 5.
Drug: Placebo
Oral tablet bid on day 1-5
Experimental: 2
Placebo day 1-5 + AZD1656 day 4, 1 week without, Gemfibrozil day 1-5 + AZD1656 day 4
Drug: AZD1656
Single dose,oral tablet
Drug: Gemfibrozil
Oral tablet bid on day 1 - 5.
Drug: Placebo
Oral tablet bid on day 1-5

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed Type 2 diabetes mellitus for at least 1 year and treated with metformin.
  • Body mass index between ≥19 and ≤42 kg/m2.

Exclusion Criteria:

  • Intake of another investigational drug within the last 30 days prior to enrolment.
  • Clinically significant illness or clinically relevant trauma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083212

Locations
Sweden
Reserach Site
Linkoping, Sweden
Research Site
Lulea, Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Stanko Skrtic AstraZeneca
Principal Investigator: Aslak Rautio Quintiles Hermelinen AB
Principal Investigator: Wolfgang Kuhn Quintiles AB
Principal Investigator: Folke Sjöberg J.J. Berzelius Clinical Research Center AB
Study Chair: Mirjana Kujacic AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01083212     History of Changes
Other Study ID Numbers: D1020C00030
Study First Received: March 8, 2010
Last Updated: June 30, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Type 2 Diabetes Mellitus
Gemfibrozil

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gemfibrozil
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014