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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neuroscience

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

Single cohort of 6 subjects

AZD2423

Intervention Type DRUG

AZD2423

Interventions

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AZD2423

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes