- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02126514
A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293 (AZD3293hADME)
A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion After Oral Administration of [14C]-AZD3293 to Healthy Male Subjects
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna
- Research Site
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria: Healthy male subjects between 18 and 55 years of age, inclusive, at the time of consent with suitable veins for cannulation or repeated venipuncture; 2) Body weight between 50 to 100 kg, inclusive; 3) Within BMI range 19 to 30 kg/m2, inclusive; 4) In good health, as determined by no clinically significant findings from medical history, physical examination with neurological examination, 12-lead ECG, and vital signs as judged by the Investigator;
-
Exclusion Criteria:
Participation in any prior study of AZD3293 or previous enrollment in the present study; 2) Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, or psychiatric disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, interfere with absorption, distribution, metabolism or excretion of drugs, or influence the results or the subject's ability to participate in the study; 3) History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
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Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: AZD3293
7 subjects will receive AZD3293
|
7 subjects will receive AZD3293
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PK parameters measured by assessment of AUC over time and Maximum observed concentration (Cmax)
Tidsram: Up to Day 25
|
Maximum observed concentration (Cmax) parameters will be calculated, for AZD3293, its metabolite; and [14C]-AZD3293-derived total radioactivity.
|
Up to Day 25
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Safety assessments including vital sign measurements, ECGs, physical examinations, clinical laboratory evaluations, and a record of adverse events (AEs).
Tidsram: Up to Day 25
|
Safety assessments including vital sign measurements, ECGs, physical examinations, clinical laboratory evaluations, and a record of adverse events (AEs), will be performed before and following investigational product administration.
|
Up to Day 25
|
|
The Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsram: Up to day 25
|
The Columbia-Suicide Severity Rating Scale (C-SSRS) will be used to assess the psychiatric health of subjects.
|
Up to day 25
|
|
Time to maximum observed concentration (tmax)
Tidsram: Up to day 25
|
Time to maximum observed concentration (tmax) will be calculated for AZD3293 and its metabolite; and [14C]-AZD3293-derived total radioactivity.
|
Up to day 25
|
|
Area under the concentration-time curve
Tidsram: Up to day 25
|
Area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0-t), will be calculated for AZD3293 and its metabolite ; and [14C]-AZD3293-derived total radioactivity concentrations.
|
Up to day 25
|
|
Area under the concentration-time curve extrapolated to infinity (AUC0-∞)
Tidsram: Up to day 25
|
Area under the concentration-time curve extrapolated to infinity (AUC0-∞), apparent terminal elimination rate constant (λZ), will be calculated for AZD3293 and its metabolite ; and [14C]-AZD3293-derived total radioactivity.
|
Up to day 25
|
|
Apparent terminal elimination half-life (t1/2)
Tidsram: Up to day 25
|
Apparent terminal elimination half-life (t1/2), will be calculated for AZD3293 and its metabolite; and [14C]-AZD3293-derived total radioactivity.
|
Up to day 25
|
|
Apparent oral clearance (CL/F)
Tidsram: Up to day 25
|
Apparent oral clearance (CL/F) (AZD3293 only), will be calculated for AZD3293 concentrations.
|
Up to day 25
|
|
Apparent volume of distribution (Vz/F)
Tidsram: Up to day 25
|
Apparent volume of distribution (Vz/F) (AZD3293 only) will be calculated for AZD3293 concentrations.
|
Up to day 25
|
|
Ratios for AUC0-
Tidsram: Up to day 25
|
Ratios for AUC0- including the ratio of total radioactivity in whole blood/plasma; and the ratio of AZD3293 in plasma and total radioactivity in plasma, will be calculated.
|
Up to day 25
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- D5010C00007
- AZD3293 hADME (Annan identifierare: AstraZeneca)
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