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Completed

NCT Number: NCT01096940

Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin

To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

San Antonio, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1656

Drug

Oral tablet, BID dose

simvastatin

Drug

Oral tablet, single dose

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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,

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 31, 2010
Registry last updated
Nov 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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