Expired Study
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Chula Vista, California


Purpose:

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.


Study summary:

This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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


Study is Available At:


Original ID:

D2920C00001


NCT ID:

NCT01176097


Secondary ID:


Study Acronym:


Brief Title:

To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes


Official Title:

A Randomized, Single-Blind, Placebo-Controlled, Single-Center, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Fasting After Single Ascending Oral Doses of AZD5658 in Type 2 Diabetes Mellitus Patients


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

20 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

AstraZeneca


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Karin Wahlander
Study Director
AstraZeneca R&DPepparedsleden 1431 83 M�lnda

Study Dates

Start Date:July 2010
Completion Date:February 2011
Completion Type:Actual
Primary Completion Date:February 2011
Primary Completion Type:Actual
Verification Date:February 2012
Last Changed Date:February 1, 2012
First Received Date:July 19, 2010

Study Outcomes

Outcome Type:Primary Outcome
Measure:To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD).
Time Frame:AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients.
Time Frame:Venous blood samples for the determination of concentrations of AZD5658 in plasma will be taken pred
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pharmacodynamics (plasma glucose and serum insulin)
Time Frame:Plasma glucose and serum insulin determined on Day -1 through Day 4
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:oral suspension,single doses
Arm Name:6 - 8 cohorts
Intervention Type:Drug
Name:AZD5658
Description:oral suspension, escalating single doses
Arm Name:6 - 8 cohorts

Study Arms

Study Arm Type:Experimental
Arm Name:6 - 8 cohorts
Description:6 patients in each cohort will receive AZD5658
Study Arm Type:Placebo Comparator
Arm Name:6 - 8 cohorts
Description:2 patients in each cohort will receive placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:AstraZeneca

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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