Neuroscience
Conditions
Keywords
Radioactive, ADME, Neuropathic pain
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.
Interventions
DRUGAZD2423
AZD2423
Sponsors
AstraZeneca
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of radioactive dose recovered in urine and faeces and total percentage | During residential period on Day 1 |
| Concentration of total radioactivity in blood and plasma | During residential period on Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| 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 physical examination | 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 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 adverse events | Range of Day -1 until follow up visit (Visit 3) |
Countries
United Kingdom
Outcome results
None listed