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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01161355
First received: June 18, 2010
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Healthy
Drug: AZD9668
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: June 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD9668
Tablets and intravenous (IV) dose
Drug: AZD9668
Tablets of AZD9668 and IV dose of [C14]AZD9668

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01161355     History of Changes
Other Study ID Numbers: D0520C00021
Study First Received: June 18, 2010
Last Updated: February 8, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Safety
tolerability
healthy
microdose

ClinicalTrials.gov processed this record on April 17, 2014