Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers (ADME)

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01147549

First received: June 11, 2010

Last updated: December 2, 2010

Last verified: December 2010

Purpose

The purpose of the study is to characterise the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD9668.

Condition	Intervention	Phase
Healthy	Drug: [C14]AZD9668	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	An Open-Label, Single-Centre, Phase I Study to Assess the Excretion, Metabolism and Plasma Pharmacokinetics Following a Single Oral Dose of 60 mg [14C]AZD9668 in Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Percentage of radioactive dose recovered in urine and faeces and total balance [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ] [ Designated as safety issue: No ]
Concentration of total radioactivity in blood and plasma [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ] [ Designated as safety issue: No ]
Plasma concentrations of AZD9668 [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ] [ Designated as safety issue: No ]
Metabolite profiling and identification in plasma and excreta [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ] [ Designated as safety issue: No ]
PK of AZD9668 (Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR ) [ Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse Events [ Time Frame: Adverse events collected prior to treatment and after treatment including follow up. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	4
Study Start Date:	June 2010
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 [C14]AZD9668	Drug: [C14]AZD9668 Oral Solution 60 mg Single Dose

Eligibility

Criteria

Inclusion Criteria:

Provision of signed, written and dated informed consent prior to any study specific procedure
Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

Exposed to radiation levels above background of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life
History or presence of any clinically significant disease or disorder in the opinion of the investigator
Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147549

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Chris O'Brien	AstraZeneca R&D, Wilmington
Principal Investigator:	Tim Mant, Professor	Quintiles Drug Research Unit, United Kingdom

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01147549 History of Changes
Other Study ID Numbers:	D0520C00016
Study First Received:	June 11, 2010
Last Updated:	December 2, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

ADME

ClinicalTrials.gov processed this record on June 18, 2013