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
Overview
- Phase
- Phase 1
- Intervention
- [C14]AZD9668
- Conditions
- Healthy
- Sponsor
- AstraZeneca
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Percentage of radioactive dose recovered in urine and faeces and total balance
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
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
Arms & Interventions
1
\[C14\]AZD9668
Intervention: [C14]AZD9668
Outcomes
Primary Outcomes
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.
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.
Plasma concentrations of AZD9668
Time Frame: Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.
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.
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
- Adverse Events(Adverse events collected prior to treatment and after treatment including follow up.)