An Open Label, Single Dose, Phase I Study to Evaluate the Excretion of Radioactivity, the Metabolic Profile, Pharmacokinetics, Safety and Tolerability Following Single Oral Administration of [14C]AZD2423 to Healthy Male Volunteers

AstraZeneca1 site in 1 country6 target enrollmentNovember 2010

ConditionsNeuroscience

InterventionsAZD2423

DrugsAZD2423

Overview

Phase: Not Applicable
Intervention: AZD2423
Conditions: Neuroscience
Sponsor: AstraZeneca
Enrollment: 6
Locations: 1
Primary Endpoint: Percentage of radioactive dose recovered in urine and faeces and total percentage
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

December 2010

Last Updated

15 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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)

Arms & Interventions

1

Single cohort of 6 subjects

Intervention: AZD2423

Outcomes

Primary Outcomes

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 8

Secondary Outcomes

Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing concomitant medications(Range of Day -1 until follow up visit (Visit 3))
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing haematology(Range of Day -1 until follow up visit (Visit 3))
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing urinalysis(Range of Day -1 until follow up visit (Visit 3))
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing body weight(Range of Day -1 until follow up visit (Visit 3))
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events(Range of Day -1 until follow up visit (Visit 3))
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing clinical chemistry(Range of Day -1 until follow up visit (Visit 3))
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing electrocardiogram(Range of Day -1 until follow up visit (Visit 3))
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing vital signs(Range of Day -1 until follow up visit (Visit 3))
Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by physical examination(Range of Day -1 until follow up visit (Visit 3))