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AZD5672 Absolute Bioavailability Study

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00746837
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
5
Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to estimate the absolute bioavailability at steady state of 2 doses of AZD5672 (50 mg and 150 mg administered orally once daily)

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Phase I Study to Assess Absolute Bioavailability of AZD5672 at Steady-state in Healthy Volunteers
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Jan 1, 2009
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Single ascending IV dose, 3 treatment periods separated by a minimum 14 day washout between doses

Drug: AZD5672
single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period
Experimental: 2

2 cohorts single IV dose + multiple oral dose period separated by a minimum of 14 days washout between IV and oral dose

Drug: AZD5672
single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period

Drug: AZD5672
50 mg od, 12 days

Drug: AZD5672
150mg od, 12 days

Outcome Measures

Primary Outcome Measures

  1. PK variables [Frequent sampling occasions during study periods]

Secondary Outcome Measures

  1. Safety variables (adverse events, blood pressure, pulse, safety lab) [During the whole treatment periods]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Provision of informed consent prior to any study specific procedures.

  • Females should not be of childbearing potential

  • Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results

Exclusion Criteria:

  • Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate

  • Unsuitable venous access for intravenous studies

  • Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Research Site Harrow London United Kingdom

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Study Director: Mark Layton, MD, PhD, AstraZeneca R&D, Charnwood, UK
  • Principal Investigator: Tania Hugo, PAREXEL Clinical Pharmacology Research Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00746837
Other Study ID Numbers:
  • D1710C00018
  • EudraCt nr 2008-003933-25
First Posted:
Sep 4, 2008
Last Update Posted:
Dec 2, 2010
Last Verified:
Nov 1, 2010
Keywords provided by , ,
AZD5672
Additional relevant MeSH terms:
N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide

Study Results

No Results Posted as of Dec 2, 2010