Study To Assess the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin
Study Details
Study Description
Brief Summary
To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 AZD1656 |
Drug: AZD1656
Oral tablet, BID dose
|
| Experimental: 2 Simvastatin |
Drug: simvastatin
Oral tablet, single dose
|
| Experimental: 3 AZD1656 + simvastatin |
Drug: AZD1656
Oral tablet, BID dose
Drug: simvastatin
Oral tablet, single dose
|
Outcome Measures
Primary Outcome Measures
- 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
- 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,]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | San Antonio | Texas | United States |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Principal Investigator: Jolene K. Berg, MD, Cetero Research, Inc.
- Study Director: Stanko Skrtic, AstraZeneca
- Study Chair: Mirjana Kujacic, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D1020C00029