| Trial ID: | L1798 |
| Source ID: | NCT00841048
|
| Associated Drug: |
Azd4017
|
| Title: |
Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses
|
| Acronym: |
MAD
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: AZD4017|DRUG: Placebo
|
| Outcome Measures: |
Primary: Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables, The variables will be measured predose and then repeatedly during the study | Secondary: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F), Blood samples for determination of AZD4017 concentration will be taken predose and repeatedly during the study.|Laboratory screen to evaluate effect on metabolic variables, Blood samples will be taken pre-dose and repeatedly during the study|Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues, Baseline and repeatedly after treatment
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
107
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose:
|
| Start Date: |
2009-02
|
| Completion Date: |
2009-05
|
| Results First Posted: |
|
| Last Update Posted: |
2009-09-30
|
| Locations: |
Research Site, Gothenburg, Sweden
|
| URL: |
https://clinicaltrials.gov/show/NCT00841048
|
