Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] AZD2423 in Volunteers

AstraZeneca

Status: Completed

Conditions: Neuroscience

Treatments: Drug: AZD2423

Study type: Observational

Funder types: Industry

Identifiers

NCT01223014

D2600C00008

Details and patient eligibility

About

Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]AZD2423 in healthy male volunteers aged 50 to 65 years (inclusive).The purpose of this study is to investigate how and how quickly AZD 2423 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.

Enrollment: 6 estimated patients

Sex: Male

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg
• Regular daily bowel movements (ie, production of at least 1 stool per day)
• Provision of signed and dated, written informed consent prior to any study specific procedures

Exclusion criteria

• Healthy volunteers exposed to radiation levels above background (eg, through X ray examination) 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
• Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1)
• History of alcohol abuse or excessive intake of alcohol defined as regular intake of more than 15 units of alcohol a week. (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer)

Trial design

6 participants in 1 patient group

1

Description:

Single cohort of 6 subjects

Treatment:

Drug: AZD2423