| Trial ID: | L6959 |
| Source ID: | NCT01176097
|
| Associated Drug: |
Azd5658
|
| Title: |
To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: AZD5658|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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: 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.
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
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| Start Date: |
2010-07
|
| Completion Date: |
2011-02
|
| Results First Posted: |
|
| Last Update Posted: |
2012-02-02
|
| Locations: |
Research Site, Chula Vista, California, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01176097
|
