Study to Investigate Single Ascending Oral Doses of AZD5213 in Healthy Male and Non Fertile Female Subjects
- The main purpose of this study is to assess the safety and tolerability of AZD5213 after single oral doses.
- Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves your body and how your body acts on the study drug) of AZD5213 in your blood and urine.
One group of subjects will be studied to see how food affects the pharmacokinetics (PK) of AZD5213 in the blood and urine. They will receive AZD5213 once after fasting overnight and then return to the clinic to receive AZD5213 after eating a high fat breakfast.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Orally-administered AZD5213 in Healthy Males and Non-fertile Females Including Randomized, Double-blind, Placebo-controlled, Parallel-group Assessment of the Safety, Tolerability & PK of Single Ascending Dose (Part 1) & an Open-label Assessment of Effect of Food on the PK (Part 2)|
- Adverse events, vital signs, physical (including neurological) examinations, clinical laboratory variables, electrocardiograms, telemetry, sleep diary (temporal and qualitative aspects), and the Columbia-Suicide Severity Rating Scale [ Time Frame: AE will be collected from admission on Day -1 until follow-up ] [ Designated as safety issue: Yes ]
- Part 1 : Investigate single-dose PK and dose proportionality of orally-administered AZD5213 [ Time Frame: Frequent timepoints within 48 hours of single dose administration ] [ Designated as safety issue: No ]
- Part 2 Investigate the potential effect of food on AZD5213 PK after administration of AZD5213 as an oral solution [ Time Frame: Frequent timepoints after volunteer consumes a high fat, high calorie breakfast, per FDA guidelines. ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
0.1 mg, 0.3 mg, 1 mg, 2 mg, 4 mg, 8 mg, 16 mg, 32 mg oral solution, single ascending doses
|Placebo Comparator: 2||Drug: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121302
|United States, Kansas|
|Overland Park, Kansas, United States|
|Principal Investigator:||David Mathews, MD||Quintiles|