NCT01096940

Brief Summary

To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 8, 2010

Status Verified

November 1, 2010

Enrollment Period

5 months

First QC Date

March 30, 2010

Last Update Submit

November 5, 2010

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusGlucose lowering

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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,

Study Arms (3)

1

EXPERIMENTAL

AZD1656

Drug: AZD1656

2

EXPERIMENTAL

Simvastatin

Drug: simvastatin

3

EXPERIMENTAL

AZD1656 + simvastatin

Drug: AZD1656Drug: simvastatin

Interventions

AZD1656DRUG

Oral tablet, BID dose

13
simvastatinDRUG

Oral tablet, single dose

23

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

AZD1656Simvastatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Jolene K. Berg, MD

    Cetero Research, Inc.

    PRINCIPAL INVESTIGATOR

  • Stanko Skrtic

    AstraZeneca

    STUDY DIRECTOR

  • Mirjana Kujacic

    AstraZeneca

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 30, 2010

First Posted

March 31, 2010

Study Start

March 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 8, 2010

Record last verified: 2010-11

Locations

US(1)