NCT01176097

Brief Summary

The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 type-2-diabetes

Timeline
Completed

Started Jul 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

July 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 2, 2012

Status Verified

February 1, 2012

Enrollment Period

7 months

First QC Date

July 19, 2010

Last Update Submit

February 1, 2012

Conditions

Type 2 Diabetes

Keywords

First in man study evaluating AZD5658 in Type 2 Diabetics.Effect of fastingSafetyTolerability

Outcome Measures

Primary Outcomes (1)

  • To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD).

    AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and 3

Secondary Outcomes (3)

  • To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients.

    Venous blood samples for the determination of concentrations of AZD5658 in plasma will be taken predose and at various times up to 72 hours postdose

  • Pharmacodynamics (plasma glucose and serum insulin)

    Plasma glucose and serum insulin determined on Day -1 through Day 4

  • Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.

Study Arms (2)

6 - 8 cohorts

EXPERIMENTAL

6 patients in each cohort will receive AZD5658

Drug: AZD5658Drug: Placebo

6 - 8 cohorts

PLACEBO COMPARATOR

2 patients in each cohort will receive placebo

Drug: AZD5658Drug: Placebo

Interventions

AZD5658DRUG

oral suspension, escalating single doses

6 - 8 cohorts
PlaceboDRUG

oral suspension,single doses

6 - 8 cohorts

Eligibility Criteria

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

You may qualify if:

  • Patients must be of non-childbearing potential.
  • Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2
  • Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin

You may not qualify if:

  • Clinically significant illness or clinically relevant trauma within 2 weeks before the first administration of the IP
  • Participation in another clinical study during the last 30 days prior to enrollment
  • Significant cardiovascular event within the last 6 months prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Chula Vista, California, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Karin Wahlander

    AstraZeneca R&DPepparedsleden 1431 83 M�lnda

    STUDY DIRECTOR

  • Mirjana Kujacic

    AstraZeneca R&DPepparedsleden 1431 83 M�lndal

    STUDY CHAIR

  • Linda Morrow

    Profil Institute for Clinical Research, Inc.855 Third Avenue, Suite 4400Chula Vista, CA 91911

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2010

First Posted

August 5, 2010

Study Start

July 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 2, 2012

Record last verified: 2012-02

Locations

US(1)