drugset / Trial / NCT01046357

A Study in Healthy Volunteers to Assess the Tolerability and Blood Levels of a Single Dose of AZD7687

NCT01046357 ↗

Phase 1 Completed 64 enrolled AstraZeneca
RandomizedSingle-groupQuadruple-blind

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.

Timeline

Start
2009-11
Primary completion
2010-06
Completion
2010-06

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD7687 Small molecule — Oral

Indications

No indication recorded.