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Clinical Trial Details

Trial ID: L2545
Source ID: NCT02935712
Associated Drug: Azd8601+Placebo (Sad)
Title: Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Male Subjects With Type II Diabetes (T2DM)
Interventions: DRUG: AZD8601+Placebo (SAD)|DRUG: AZD8601+Placebo|DRUG: Placebo+Placebo
Outcome Measures: Primary: Safety of AZD8601 by assessing summary of adverse events (Part A), To evaluate the safety by assessing the adverse event after administration of a single dose of AZD8601 to male subjects with T2DM (Part A)., Part A: From screening (Day -28) up to Day 29|Safety of AZD8601 by assessing number of subjects with clinically significant blood pressure (Part A), To evaluate the safety by assessing the number of subjects with clinically significant blood pressure after administration of single dose of AZD8601 to male subjects with T2DM (Part A)., Part A: Day 1 to Day 8|Safety of AZD8601 by assessing number of subjects with Clinically significant pulse (Part A), To evaluate the safety by assessing the number of subjects with clinically significant pulse after administration of single dose of AZD8601 to male subjects with T2DM (Part A)., Part A: Day 1 to Day 8|Safety of AZD8601 by assessing number of subjects with Clinically significant 12-lead electrocardiograms (ECGs) (Part A), To evaluate the safety by assessing the number of subjects with clinically significant ECGs after administration of single dose of AZD8601 to male subjects with T2DM (Part A)., Part A: Day 1 to Day 8|Safety of AZD8601 by assessing number of subjects with clinically significant hematology parameters (Part A), To evaluate the safety by assessing the number of subjects with clinically significant hematology parameters after administration of single dose of AZD8601 to male subjects with T2DM (Part A)., Part A: Day 1 to Day 8|Safety of AZD8601 by assessing number of subjects with clinically significant clinical chemistry laboratory results (Part A), To evaluate the safety by assessing the number of subjects with clinically significant clinical chemistry laboratory results after administration of single dose of AZD8601 to male subjects with T2DM (Part A)., Part A: Day 1 to Day 8|Safety of AZD8601 by assessing number of subjects with clinically significant urinalysis (Part A), To evaluate the safety by assessing the number of subjects with clinically significant urinalysis after administration of single dose of AZD8601 to male subjects with T2DM (Part A)., Part A: Day 1 to Day 8|Safety of AZD8601 by assessing summary of adverse events (Part B), To evaluate the safety by assessing the adverse event after administration of a single dose of AZD8601 to male subjects with T2DM (Part B)., Part B: From screening up to Day 15|Safety of AZD8601 by assessing number of subjects with clinically significant blood pressure (Part B), To evaluate the safety by assessing the number of subjects with clinically significant blood pressure after administration of single dose of AZD8601 to male subjects with T2DM (Part B)., Part B: Day 1 to Day 2|Safety of AZD8601 by assessing number of subjects with Clinically significant pulse (Part B), To evaluate the safety by assessing the number of subjects with clinically significant pulse after administration of single dose of AZD8601 to male subjects with T2DM (Part B)., Part B: Day 1 to Day 2|Safety of AZD8601 by assessing number of subjects with Clinically significant 12-lead electrocardiograms (ECGs) (Part B), To evaluate the safety by assessing the number of subjects with clinically significant ECGs after administration of single dose of AZD8601 to male subjects with T2DM (Part B)., Part B: Day 1 to Day 2|Safety of AZD8601 by assessing number of subjects with clinically significant hematology parameters (Part B), To evaluate the safety by assessing the number of subjects with clinically significant hematology parameters after administration of single dose of AZD8601 to male subjects with T2DM (Part B)., Part B: Day 1 to Day 2|Safety of AZD8601 by assessing number of subjects with clinically significant clinical chemistry laboratory results (Part B), To evaluate the safety by assessing the number of subjects with clinically significant clinical chemistry laboratory results after administration of single dose of AZD8601 to male subjects with T2DM (Part B)., Part B: Day 1 to Day 2|Safety of AZD8601 by assessing number of subjects with clinically significant urinalysis (Part B), To evaluate the safety by assessing the number of subjects with clinically significant urinalysis after administration of single dose of AZD8601 to male subjects with T2DM (Part B)., Part B: Day 1 to Day 2 |
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Parexel|Spandauer Damm 130|14050|Berlin, Germany
Gender: MALE
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 44
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2016-12-16
Completion Date: 2018-01-08
Results First Posted:
Last Update Posted: 2020-01-18
Locations: Research Site, Berlin, 14050, Germany
URL: https://clinicaltrials.gov/show/NCT02935712