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Completed

NCT Number: NCT01223014

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

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Key information

Conditions

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

Age range

50 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AZD2423

Drug

AZD2423

Primary outcomes

  1. Percentage of radioactive dose recovered in urine and faeces and total percentage

    Time frame: During residential period on Day 1

  2. Percentage of radioactive dose recovered in urine and faeces and total percentage

    Time frame: During residential period on Day 2

  3. Percentage of radioactive dose recovered in urine and faeces and total percentage

    Time frame: During residential period on Day 3

  4. Percentage of radioactive dose recovered in urine and faeces and total percentage

    Time frame: During residential period on Day 4

  5. Percentage of radioactive dose recovered in urine and faeces and total percentage

    Time frame: During residential period on Day 5

  6. Percentage of radioactive dose recovered in urine and faeces and total percentage

    Time frame: During residential period on Day 6

  7. Percentage of radioactive dose recovered in urine and faeces and total percentage

    Time frame: During residential period on Day 7

  8. Percentage of radioactive dose recovered in urine and faeces and total percentage

    Time frame: During residential period on Day 8

  9. Concentration of total radioactivity in blood and plasma

    Time frame: During residential period on Day 1

  10. Concentration of total radioactivity in blood and plasma

    Time frame: During residential period on Day 2

  11. Concentration of total radioactivity in blood and plasma

    Time frame: During residential period on Day 3

  12. Concentration of total radioactivity in blood and plasma

    Time frame: During residential period on Day 4

  13. Concentration of total radioactivity in blood and plasma

    Time frame: During residential period on Day 5

  14. Concentration of total radioactivity in blood and plasma

    Time frame: During residential period on Day 6

  15. Concentration of total radioactivity in blood and plasma

    Time frame: During residential period on Day 7

  16. Concentration of total radioactivity in blood and plasma

    Time frame: During residential period on Day 8

Secondary outcomes

  1. Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events

    Time frame: Range of Day -1 until follow up visit (Visit 3)

  2. Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing concomitant medications

    Time frame: Range of Day -1 until follow up visit (Visit 3)

  3. Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing clinical chemistry

    Time frame: Range of Day -1 until follow up visit (Visit 3)

  4. Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing haematology

    Time frame: Range of Day -1 until follow up visit (Visit 3)

  5. Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing urinalysis

    Time frame: Range of Day -1 until follow up visit (Visit 3)

  6. Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing vital signs

    Time frame: Range of Day -1 until follow up visit (Visit 3)

  7. Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing body weight

    Time frame: Range of Day -1 until follow up visit (Visit 3)

  8. Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing electrocardiogram

    Time frame: Range of Day -1 until follow up visit (Visit 3)

  9. Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by physical examination

    Time frame: Range of Day -1 until follow up visit (Visit 3)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: ADME

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 18, 2010
Registry last updated
Feb 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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