Clinical trial NCT01096940: Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Glucose lowering
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-03-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 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:
measure: 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)
timeFrame: Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)
measure: 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.
timeFrame: Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)
measure: 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.
timeFrame: Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)
measure: 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.
timeFrame: At pre entry, during the study days,
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Cetero Research, Inc.
name: Jolene K. Berg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Stanko Skrtic
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Mirjana Kujacic
role: STUDY_CHAIR
References: