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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01046357
First received: December 3, 2009
Last updated: February 10, 2012
Last verified: February 2012
  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 1

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: AstraZeneca
ClinicalTrials.gov Identifier: NCT01046357     History of Changes
Other Study ID Numbers: D2710C00001
Study First Received: December 3, 2009
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
First in human
Safety

ClinicalTrials.gov processed this record on April 20, 2014