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Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01096940
First received: March 30, 2010
Last updated: November 5, 2010
Last verified: November 2010
History of Changes
  Purpose

To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: AZD1656
Drug: simvastatin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Randomized, Open-label, 3-way Crossover Phase I Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Pharmacokinetics and Pharmacodynamics of Simvastatin During Coadministration With AZD1656 and to Evaluate the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin

Resource links provided by NLM:

Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin (including simvastatin acid) and vice versa by assessment of AUC(0-24) and Cmax. [ Time Frame: Frequent blood samples for PK analysis will be drawn during 24 hours post morning dose on day 4 in each treatment period (1-3) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin and simvastatin acid and vice versa by assessment of tmax, t1/2 and CL/F (only for AZD1656) [ Time Frame: Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3) ] [ Designated as safety issue: No ]
  • To evaluate the steady state pharmacokinetics of the AZD1656 metabolite when AZD1656 is administered with and without simvastatin, by assessment of AUC(0-24), Cmax and tmax. [ Time Frame: Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3) ] [ Designated as safety issue: No ]
  • To evaluate the effect of AZD1656 on the pharmacodynamics of simvastatin by assessment of AUC(0-t) and Cmax of active 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors. [ Time Frame: Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3) ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of AZD1656 alone and in combination with simvastatin by assessments of adverse events, laboratory variables, electrocardiogram, blood pressure, pulse, results of physical examination, and weight. [ Time Frame: At pre entry, during the study days, ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: March 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD1656
 Drug: AZD1656
Oral tablet, BID dose
Experimental: 2
Simvastatin
 Drug: simvastatin
Oral tablet, single dose
Experimental: 3
AZD1656 + simvastatin
 Drug: AZD1656
Oral tablet, BID dose
Drug: simvastatin
Oral tablet, single dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any metformin or metformin with one other oral anti-diabetic drug (OAD)
  • Body mass index between greater than or equal to 19 and less than or equal to 42 kg/m2
  • HbA1c greater than 6.5% at enrollment

Exclusion Criteria:

  • Clinically significant illness or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP
  • Significant cardiovascular event within the last 6 months prior to enrollment (eg, myocardial infarction/acute coronary syndrome, revascularisation procedure, stroke or transient ischaemic attack) or heart failure New York Heart Association (NYHA) class III-IV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096940

Locations
United States, Texas
Research Site
San Antonio, Texas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Jolene K. Berg, MD Cetero Research, Inc.
Study Director: Stanko Skrtic AstraZeneca
Study Chair: Mirjana Kujacic AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01096940     History of Changes
Other Study ID Numbers: D1020C00029
Study First Received: March 30, 2010
Last Updated: November 5, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Type 2 Diabetes Mellitus
Glucose lowering

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013