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

NCT01147549 | Completed Phase 1

• 1 other identifier: D0520C00016
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

ADME

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Adverse Events

  Adverse events collected prior to treatment and after treatment including follow up.

Study Arms (1)

1

EXPERIMENTAL

\[C14\]AZD9668

Drug: [C14]AZD9668

Interventions

[C14]AZD9668 DRUG

Oral Solution 60 mg Single Dose

1

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Study Officials

• Chris O'Brien

  AstraZeneca R&D, Wilmington

  STUDY DIRECTOR

• Tim Mant, Professor

  Quintiles Drug Research Unit, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 22, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 3, 2010

Record last verified: 2010-12

Locations

GB (1)