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

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

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 Overview

• Status: Completed
• Conditions: Neuroscience
• Intervention / Treatment: Drug: AZD2423

• Study Type: Observational
• Enrollment (Anticipated): 6

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic/community sample

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Single cohort of 6 subjects	Drug: AZD2423; AZD2423

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of radioactive dose recovered in urine and faeces and total percentage	During residential period on Day 1
Percentage of radioactive dose recovered in urine and faeces and total percentage	During residential period on Day 2
Percentage of radioactive dose recovered in urine and faeces and total percentage	During residential period on Day 3
Percentage of radioactive dose recovered in urine and faeces and total percentage	During residential period on Day 4
Percentage of radioactive dose recovered in urine and faeces and total percentage	During residential period on Day 5
Percentage of radioactive dose recovered in urine and faeces and total percentage	During residential period on Day 6
Percentage of radioactive dose recovered in urine and faeces and total percentage	During residential period on Day 7
Percentage of radioactive dose recovered in urine and faeces and total percentage	During residential period on Day 8
Concentration of total radioactivity in blood and plasma	During residential period on Day 1
Concentration of total radioactivity in blood and plasma	During residential period on Day 2
Concentration of total radioactivity in blood and plasma	During residential period on Day 3
Concentration of total radioactivity in blood and plasma	During residential period on Day 4
Concentration of total radioactivity in blood and plasma	During residential period on Day 5
Concentration of total radioactivity in blood and plasma	During residential period on Day 6
Concentration of total radioactivity in blood and plasma	During residential period on Day 7
Concentration of total radioactivity in blood and plasma	During residential period on Day 8

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 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 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 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 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 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 physical examination	Range of Day -1 until follow up visit (Visit 3)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Biljana Lilja, AstraZeneca; Principal Investigator: Marianne Kasti, Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: October 15, 2010
• First Submitted That Met QC Criteria: October 15, 2010
• First Posted (Estimate): October 18, 2010

Study Record Updates

• Last Update Posted (Estimate): February 8, 2011
• Last Update Submitted That Met QC Criteria: February 6, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Neuropathic pain; ADME; Radioactive
• Other Study ID Numbers: D2600C00008