A Study in Healthy Volunteers to Assess the Tolerability and Blood Levels of a Single Dose of AZD7687
- Registration Number
- NCT01046357
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 64
Inclusion Criteria
- Healthy
- BMI between 19-30
Exclusion Criteria
- No blood donation prior 30 days
- No other clinical study prior 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active AZD7687 AZD7687 oral suspension Placebo Placebo placebo oral suspension
- Primary Outcome Measures
Name Time Method Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)
- Secondary Outcome Measures
Name Time Method Plasma concentrations of AZD7687 and plasma pharmacokinetic parameters. Exploratory pharmacogenetic blood sampling. Pharmacodynamic biomarker sampling; blood samples.
Trial Locations
- Locations (1)
Research Site
🇺🇸Overland Park, Kansas, United States