Major depressive disorder
Conditions
Interventions
Single dose (Japanese): Double-blind, placebo-controlled 1, 3, 10, 45, 60 mg (NC-2800) will be administered at fasting, or 30 mg (NC-2800) will be administered at fasting / after meal (2-way crossover
Sponsors
Hayamizu Koki
Japan Agency for Medical Research and Development
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese or Caucasian males 2) Aged >=20 and =18.5 and ==18.5 and =<30.0 (Caucasian) 4) Subjects who are able to give written consent of their own free will
Exclusion criteria
Exclusion criteria: 1)Subjects who have a past history of drug allergy 2)Subjects who have a present or past history of gastrointestinal, heart, liver or kidney, etc. disease that may affect the absorption, metabolism, or excretion of the drug. Particularly concerning liver function, persons who are assessed by the investigator/subinvestigator to be ineligible in consideration of the range of reference values of various laboratory tests. 3)Subjects who have a history of major surgery in the gastrointestinal tract, such as gastrectomy, gastroenterostomy, or enterectomy, that affects the absorption of drugs 4)Subjects who have a complication or past history of arrhythmia, such as ventricular tachycardia or QT prolongation, that requires treatment 5)Subjects who have a family history of ventricular tachycardia, congenital long QT syndrome, or unexplained arrhythmia 6)Subjects who have a past history of clinically significant respiratory disease or a history of respiratory surgery 7)Subjects who have a history of a diagnosis of chronic bowel movement disorder (e.g., chronic constipation requiring treatment, chronic diarrhea, or irritable bowel syndrome) 8)Subjects who have a past history of convulsive seizure or presyncope (excluding simple febrile seizure) 9)Subjects who have a past history of mental/neurological diseases 10)Subjects who have alcohol or drug dependence 11)Subjects who have nicotine dependence, use nicotine products (e.g., nicotine patch) or who smoke 12)Subjects who test positive for drug abuse with urinary drug screening 13)Subjects who have electrolyte abnormalities including hypokalemia (serum K: 2.5 mg/dL) 14)Subjects who have a suicide risk (who responded "Yes" to Question 4 or 5 about "Suicidal ideation" on the Columbia Suicide Severity Rating Scale [C-SSRS] at screening) 15)Subjects who are tested positive for HBs antigen, serum reaction for syphilis, HCV antibody, or HIV antigen/antibody 16)Subjects with abnormal ECG findings or prolonged QT/QTc interval (e.g., QTc interval exceeding 450 msec by Fridericia correction method) at screening 17)Subjects who have taken supplements, grapefruit (fruit or juice) or St. John's wort within 2 weeks before the study treatment 18)Subjects who have taken any drugs within 2 weeks or 5 half-lives, whichever is longer, before the start of the study treatment 19)Subjects who have taken any drug containing opioid (e.g., antitussives such as codeine) within 4 weeks before the study treatment 20)Subjects who have taken any known cytochrome P450 system inhibitors (e.g., itraconazole, clopidogrel) or inducers (e.g., rifampicin) within 2 months before the study treatment 21)Subjects who have taken any other investigational drug within 3 months before the study treatment 22)Subjects who have received blood transfusion within 3 months, who have donated >=400 mL of whole blood within 3 months or >=200 mL of whole blood within 1 month, or who have donated blood components within 2 weeks before the study treatment 23)Subjects who are unable to practice proper contraception during the period from hospital admission to 3 months after discharge 24)Subjects who are assessed to be ineligible as study subjects by the investigator/subinvestigator 25) Subjects who have orthostatic hypotension at screening (a decrease in systolic blood pressure of >=20 mmHg or a decrease in absolute systolic blood pressure to below 90 mmHg, or a decrease in diastolic blood pressure of >=10 mmHg,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety 1) Incidence rate of adverse events 2) Incidence rate of adverse reactions 3) Echocardiography 4) ECG (24-hour Holter ECG, monitor ECG, 12-lead ECG) 5) Electroencephalography (EEG) (Qualitative EEG) Pharmacokinetics 1) Plasma concentrations (Unchanged drug/metabolite M1) 2) Urinary excretion (Unchanged drug/metabolite M1), excretion rate 3) Pharmacokinetic parameters (Cmax, AUC, Tmax, T1/2, etc.) | — |
Contacts
Public ContactTomoko Kobayashi
SOUSEIKAI Sumida Hospital
Outcome results
None listed