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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Percentage of radioactive dose recovered in urine and faeces and total balance
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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 (Drug)
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.)