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Phase I, Exploratory, Single Centre, Single Oral Dose AZD9668 and Intravenous Microdose of [C14] AZD9668, Healthy Subject

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ClinicalTrials.gov Identifier: NCT01161355
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : February 9, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The primary objective of this study is to assess the absolute bioavailability and to evaluate pharmacokinetic parameters of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668 in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD9668 Phase 1

Detailed Description:
This is an exploratory study to assess the absolute bioavailability of a single oral dose of AZD9668 with respect to an intra-venous microdose of [14C]AZD9668 in healthy male subjects.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Exploratory Study to Assess the Absolute Bioavailability of a Single Oral Dose of AZD9668 With Respect to an Intra-venous Microdose of [14C]AZD9668 in Healthy Male Subjects
Study Start Date : June 2010
Primary Completion Date : June 2010
Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: AZD9668
Tablets and intravenous (IV) dose
Drug: AZD9668
Tablets of AZD9668 and IV dose of [C14]AZD9668



Primary Outcome Measures :
  1. The absolute bioavailability and evaluation of pharmacokinetic parameters (AUC, AUC (0-t), Cmax, t½, tmax, and MRT of of a single oral dose and a radiolabelled intravenous microdose of [14C]AZD9668 [ Time Frame: Multiple Pharmacokinetic blood samples for up to 96 hours following drug administration ]

Secondary Outcome Measures :
  1. Safety and tolerability of AZD9668: Adverse events, clinical chemistry, haematology, urinalysis, vital signs, electrocardiogram, physical examination [ Time Frame: measured within 21 days of drug administration and up to 7 days following drug administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at least 50 kg and no more than 100 kg.

Exclusion Criteria:

  • Any clinically significant disease or disorder
  • Any clinically significant abnormalities at screening examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161355


Locations
United Kingdom
Research Site
Ruddington, Nottingham, United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joanna Marks-Konczalik AstraZeneca
Principal Investigator: Sharan Sidhu, MB ChB, BAO, Quintiles, Inc.

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01161355     History of Changes
Other Study ID Numbers: D0520C00021
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: February 9, 2011
Last Verified: February 2011

Keywords provided by AstraZeneca:
Safety
tolerability
healthy
microdose