Clinical trial NCT01223014: Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] AZD2423 in Volunteers
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroscience
Keywords: Radioactive
ADME
Neuropathic pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 6
Sex: MALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic/community sample

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.


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)

Primary outcomes:
measure: Percentage of radioactive dose recovered in urine and faeces and total percentage
timeFrame: During residential period on Day 1
measure: Percentage of radioactive dose recovered in urine and faeces and total percentage
timeFrame: During residential period on Day 2
measure: Percentage of radioactive dose recovered in urine and faeces and total percentage
timeFrame: During residential period on Day 3
measure: Percentage of radioactive dose recovered in urine and faeces and total percentage
timeFrame: During residential period on Day 4
measure: Percentage of radioactive dose recovered in urine and faeces and total percentage
timeFrame: During residential period on Day 5
measure: Percentage of radioactive dose recovered in urine and faeces and total percentage
timeFrame: During residential period on Day 6
measure: Percentage of radioactive dose recovered in urine and faeces and total percentage
timeFrame: During residential period on Day 7
measure: Percentage of radioactive dose recovered in urine and faeces and total percentage
timeFrame: During residential period on Day 8
measure: Concentration of total radioactivity in blood and plasma
timeFrame: During residential period on Day 1
measure: Concentration of total radioactivity in blood and plasma
timeFrame: During residential period on Day 2
measure: Concentration of total radioactivity in blood and plasma
timeFrame: During residential period on Day 3
measure: Concentration of total radioactivity in blood and plasma
timeFrame: During residential period on Day 4
measure: Concentration of total radioactivity in blood and plasma
timeFrame: During residential period on Day 5
measure: Concentration of total radioactivity in blood and plasma
timeFrame: During residential period on Day 6
measure: Concentration of total radioactivity in blood and plasma
timeFrame: During residential period on Day 7
measure: Concentration of total radioactivity in blood and plasma
timeFrame: During residential period on Day 8
Secondary outcomes:
measure: Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events
timeFrame: Range of Day -1 until follow up visit (Visit 3)
measure: Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing concomitant medications
timeFrame: Range of Day -1 until follow up visit (Visit 3)
measure: Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing clinical chemistry
timeFrame: Range of Day -1 until follow up visit (Visit 3)
measure: Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing haematology
timeFrame: Range of Day -1 until follow up visit (Visit 3)
measure: Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing urinalysis
timeFrame: Range of Day -1 until follow up visit (Visit 3)
measure: Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing vital signs
timeFrame: Range of Day -1 until follow up visit (Visit 3)
measure: Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing body weight
timeFrame: Range of Day -1 until follow up visit (Visit 3)
measure: Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing electrocardiogram
timeFrame: Range of Day -1 until follow up visit (Visit 3)
measure: Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by physical examination
timeFrame: Range of Day -1 until follow up visit (Visit 3)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Biljana Lilja
role: STUDY_DIRECTOR
affiliation: Quintiles, Inc.
name: Marianne Kasti
role: PRINCIPAL_INVESTIGATOR
References: