Skip to main content
OpenTrials
Completed

NCT Number: NCT01046357

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy
  • BMI between 19-30

Exclusion criteria

  • No blood donation prior 30 days
  • No other clinical study prior 3 months

Treatment and study plan

AZD7687

Drug

Single oral dose

Placebo

Drug

Single oral dose

Primary outcomes

  1. Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)

Secondary outcomes

  1. Plasma concentrations of AZD7687 and plasma pharmacokinetic parameters.

  2. Exploratory pharmacogenetic blood sampling.

  3. Pharmacodynamic biomarker sampling; blood samples.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 12, 2010
Registry last updated
Feb 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.