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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [C14]AZD9668

• Registration Number: NCT01147549
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	[C14]AZD9668	\[C14\]AZD9668

Primary Outcome Measures

Name	Time	Method
Percentage of radioactive dose recovered in urine and faeces and total balance	Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Concentration of total radioactivity in blood and plasma	Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Plasma concentrations of AZD9668	Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
Metabolite profiling and identification in plasma and excreta	Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
PK of AZD9668 (Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR )	Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Adverse events collected prior to treatment and after treatment including follow up.

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom