NCT00817505

Brief Summary

To evaluate the bioavailability of a tablet of AZD1656.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 3, 2009

Status Verified

November 1, 2009

Enrollment Period

3 months

First QC Date

December 24, 2008

Last Update Submit

November 2, 2009

Conditions

Type 1 Diabetes

Keywords

Type I diabetesbioavailability

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)

    Blood samples taken up to 72 hours

Secondary Outcomes (2)

  • Pharmacodynamic variables (Plasma glucose)

    Taken repeatedly during treatment periods

  • Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)

    Taken during treatment periods

Study Arms (3)

1

ACTIVE COMPARATOR

AZD1656 tablet + food

Drug: AZD1656

2

ACTIVE COMPARATOR

AZD1656 susp. without food

Drug: AZD1656

3

ACTIVE COMPARATOR

AZD1656 tablet

Drug: AZD1656

Interventions

AZD1656DRUG

Single dose oral tablet

123

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, type I diabetes patients, female with non child-bearing potential.
  • Treated with insulin for more than 3 years. Well controlled HbA1c.
  • Have a body mass index (BMI) ≥19 and ≤35

You may not qualify if:

  • Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
  • Daily use of nicotine containing substances.

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 1

Interventions

AZD1656

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Klas Malmberg, MD, PhD, Prof

    AstraZeneca R&D Mölndal

    STUDY DIRECTOR

  • Emanuel P DeNoia, MD

    Healthcare Discoveries LLC Icon Development Solutions

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 24, 2008

First Posted

January 6, 2009

Study Start

December 1, 2008

Primary Completion

March 1, 2009

Study Completion

September 1, 2009

Last Updated

November 3, 2009

Record last verified: 2009-11

Locations

US(1)