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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01046357

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: AZD7687 Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Plasma concentrations of AZD7687 and plasma pharmacokinetic parameters. [ Designated as safety issue: No ]
Exploratory pharmacogenetic blood sampling. [ Designated as safety issue: No ]
Pharmacodynamic biomarker sampling; blood samples. [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	November 2009
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active AZD7687 oral suspension	Drug: AZD7687 Single oral dose
Experimental: Placebo placebo oral suspension	Drug: Placebo Single oral dose

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy
BMI between 19-30

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046357

Locations

United States, Kansas
Research Site
Overland Park, Kansas, United States

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01046357 History of Changes
Other Study ID Numbers:	D2710C00001
Study First Received:	December 3, 2009
Last Updated:	June 22, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

First in human
Safety

ClinicalTrials.gov processed this record on February 09, 2012