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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01161355

Collaborator

(none)

Enrollment

Locations

Arm

Patients Per Site

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jun 1, 2010

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: AZD9668

Tablets and intravenous (IV) dose

Drug: AZD9668

Tablets of AZD9668 and IV dose of [C14]AZD9668

Outcome Measures

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 [Multiple Pharmacokinetic blood samples for up to 96 hours following drug administration]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Ruddington	Nottingham	United Kingdom
2	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01161355

Other Study ID Numbers:

D0520C00021

First Posted:

Jul 13, 2010

Last Update Posted:

Feb 9, 2011

Last Verified:

Feb 1, 2011

Keywords provided by , ,

Study Results

No Results Posted as of Feb 9, 2011