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

AstraZeneca6 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neuroscience

Interventions

AZD2423DRUG

AZD2423

Eligibility

Sex: MALEMin age: 50 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

Percentage of radioactive dose recovered in urine and faeces and total percentage

Time frame: During residential period on Day 1

Percentage of radioactive dose recovered in urine and faeces and total percentage

Time frame: During residential period on Day 2

Percentage of radioactive dose recovered in urine and faeces and total percentage

Time frame: During residential period on Day 3

Percentage of radioactive dose recovered in urine and faeces and total percentage

Time frame: During residential period on Day 4

Percentage of radioactive dose recovered in urine and faeces and total percentage

Time frame: During residential period on Day 5

Percentage of radioactive dose recovered in urine and faeces and total percentage

Time frame: During residential period on Day 6

Percentage of radioactive dose recovered in urine and faeces and total percentage

Time frame: During residential period on Day 7

Percentage of radioactive dose recovered in urine and faeces and total percentage

Time frame: During residential period on Day 8

Concentration of total radioactivity in blood and plasma

Time frame: During residential period on Day 1

Concentration of total radioactivity in blood and plasma

Time frame: During residential period on Day 2

Data from ClinicalTrials.gov

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Secondary Outcomes

Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events