Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096940
• Other study ID #: D1020C00029
• Status: Completed
• Phase: Phase 1
• First received: March 30, 2010
• Last updated: November 5, 2010
• Start date: March 2010
• Est. completion date: August 2010

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• AZD1656
Oral tablet, BID dose
• simvastatin
Oral tablet, single dose

Locations

Country	Name	City	State
United States	Research Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Frequent blood samples for PK analysis will be drawn during 24 hours post morning dose on day 4 in each treatment period (1-3)	No
Secondary	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)		Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)	No
Secondary	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.		Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)	No
Secondary	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.		Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)	No
Secondary	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.		At pre entry, during the study days,	No