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

NCT01223014 | Completed

• 1 other identifier: D2600C00008
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroscience

Keywords

Radioactive; ADME; Neuropathic pain

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (9)

• 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)

Study Arms (1)

1

Single cohort of 6 subjects

Drug: AZD2423

Interventions

AZD2423 DRUG

AZD2423

1

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic/community sample

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pharmacogenetic samples

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Biljana Lilja

  AstraZeneca

  STUDY DIRECTOR

• Marianne Kasti

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 8, 2011

Record last verified: 2011-02

Locations

GB (1)