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

Neuroscience Clinical Trial

— ADME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223014
• Other study ID #: D2600C00008
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2010
• Last updated: February 6, 2011
• Start date: November 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 65 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Neuroscience

Intervention

Drug:
• AZD2423
AZD2423

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of radioactive dose recovered in urine and faeces and total percentage		During residential period on Day 1	No
Primary	Percentage of radioactive dose recovered in urine and faeces and total percentage		During residential period on Day 2	No
Primary	Percentage of radioactive dose recovered in urine and faeces and total percentage		During residential period on Day 3	No
Primary	Percentage of radioactive dose recovered in urine and faeces and total percentage		During residential period on Day 4	No
Primary	Percentage of radioactive dose recovered in urine and faeces and total percentage		During residential period on Day 5	No
Primary	Percentage of radioactive dose recovered in urine and faeces and total percentage		During residential period on Day 6	No
Primary	Percentage of radioactive dose recovered in urine and faeces and total percentage		During residential period on Day 7	No
Primary	Percentage of radioactive dose recovered in urine and faeces and total percentage		During residential period on Day 8	No
Primary	Concentration of total radioactivity in blood and plasma		During residential period on Day 1	No
Primary	Concentration of total radioactivity in blood and plasma		During residential period on Day 2	No
Primary	Concentration of total radioactivity in blood and plasma		During residential period on Day 3	No
Primary	Concentration of total radioactivity in blood and plasma		During residential period on Day 4	No
Primary	Concentration of total radioactivity in blood and plasma		During residential period on Day 5	No
Primary	Concentration of total radioactivity in blood and plasma		During residential period on Day 6	No
Primary	Concentration of total radioactivity in blood and plasma		During residential period on Day 7	No
Primary	Concentration of total radioactivity in blood and plasma		During residential period on Day 8	No
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes