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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01147549

Acronym

ADME

Enrollment

Registered

2010-06-22

Start date

2010-06-30

Completion date

2010-07-31

Last updated

2010-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ADME

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.

Interventions

DRUG[C14]AZD9668

Oral Solution 60 mg Single Dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026