A Study in Healthy Volunteers to Assess the Tolerability and Blood Levels of a Single Dose of AZD7687
This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single ascending dose study in healthy male volunteers conducted at a single centre. The effect of food on the pharmacokinetics of AZD7687 will also be studied.
The study will consist of two parts, a dose escalation part and a food interaction part. The two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation. Each subject will receive dose only once, except for the volunteers included in the dose steps repeated for food interaction.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||A Randomized, Blind, Placebo-controlled, Single-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD7687 After Single Ascending Oral Doses|
- Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)
- Plasma concentrations of AZD7687 and plasma pharmacokinetic parameters.
- Exploratory pharmacogenetic blood sampling.
- Pharmacodynamic biomarker sampling; blood samples.
|Study Start Date:||November 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
AZD7687 oral suspension
Single oral dose
placebo oral suspension
Single oral dose
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046357
|United States, Kansas|
|Overland Park, Kansas, United States|