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OpenTrials
Completed

NCT Number: NCT01147549

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

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

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Key information

Conditions

Healthy

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[C14]AZD9668

Drug

Oral Solution 60 mg Single Dose

Primary outcomes

  1. 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.

  2. 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.

  3. Plasma concentrations of AZD9668

    Time frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.

  4. 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.

  5. 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.

Secondary outcomes

  1. Adverse Events

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: ADME

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2010
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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