Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: AZD1656; Drug: simvastatin

• Registration Number: NCT01096940
• Lead Sponsor: AstraZeneca

Brief Summary

To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-05
• Last Update Posted: 2010-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD1656	AZD1656
2	simvastatin	Simvastatin
3	AZD1656	AZD1656 + simvastatin
3	simvastatin	AZD1656 + simvastatin

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)
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,

Trial Locations

Locations (1)

Research Site; 🇺🇸 San Antonio, Texas, United States