Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin

Phase 1CompletedNCT01096940

AstraZeneca44 enrolled

Overview

To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

AZD1656DRUG

Oral tablet, BID dose

simvastatinDRUG

Oral tablet, single dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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

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)

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)

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)

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,

Data from ClinicalTrials.gov

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