jRCT2071210033RecruitingNot Applicable
Phase I Study of NC-2800
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Nippon Chemiphar Co., Ltd.
- Enrollment
- 104
- Primary Endpoint
- ECG
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 20age 0month 0week old over to 45age 0month 0week old not (—)
- Sex
- Male
Inclusion Criteria
- •Japanese or Caucasian males
- •Aged >=20 and <45 years (at the time of informed consent)
- •BMI: >=18.5 and =<25.0 (Japanese) or >=18.5 and =<30.0 (Caucasian)
- •Subjects who are able to give written consent of their own free will
Exclusion Criteria
- •Subjects who have a past history of drug allergy
- •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.
- •Subjects who have a history of major surgery in the gastrointestinal tract, such as gastrectomy, gastroenterostomy, or enterectomy, that affects the absorption of drugs
- •Subjects who have a complication or past history of arrhythmia, such as ventricular tachycardia or QT prolongation, that requires treatment
- •Subjects who have a family history of ventricular tachycardia, congenital long QT syndrome, or unexplained arrhythmia
- •Subjects who have a past history of clinically significant respiratory disease or a history of respiratory surgery
- •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)
- •Subjects who have a past history of convulsive seizure or presyncope (excluding simple febrile seizure)
- •Subjects who have a past history of mental/neurological diseases
- •Subjects who have alcohol or drug dependence
- •Subjects who have nicotine dependence, use nicotine products (e.g., nicotine patch) or who smoke
- •Subjects who test positive for drug abuse with urinary drug screening
- •Subjects who have electrolyte abnormalities including hypokalemia (serum K: <3.5 mEq/L) and hypermagnesemia (serum Mg: >2.5 mg/dL)
- •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)
- •Subjects who are tested positive for HBs antigen, serum reaction for syphilis, HCV antibody, or HIV antigen/antibody
- •Subjects with abnormal ECG findings or prolonged QT/QTc interval (e.g., QTc interval exceeding 450 msec by Fridericia correction method) at screening
- •Subjects who have taken supplements, grapefruit (fruit or juice) or St. John's wort within 2 weeks before the study treatment
- •Subjects who have taken any drugs within 2 weeks or 5 half-lives, whichever is longer, before the start of the study treatment
- •Subjects who have taken any drug containing opioid (e.g., antitussives such as codeine) within 4 weeks before the study treatment
- •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
- •Subjects who have taken any other investigational drug within 3 months before the study treatment
- •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
- •Subjects who are unable to practice proper contraception during the period from hospital admission to 3 months after discharge
- •Subjects who are assessed to be ineligible as study subjects by the investigator/subinvestigator
- •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, within 3 minutes following a change in position from supine to upright)
- •The following exclusion criteria will be added for the multiple dose study.
- •Subjects who use glasses only for vision correction or use colored contact lenses
- •Subjects who have a right visual acuity (naked eye or corrected) of <0.3, or a history of ophthalmologic surgery (e.g., LASIK)
- •Subjects who have imbalanced pupil movement or pigment near the pupil, as detected on the ophthalmologic examination at screening
Outcomes
Primary Outcomes
ECG
24-hour Holter ECG, monitor ECG, 12-lead ECG
Electroencephalography (EEG)
Qualitative EEG
Plasma concentrations
Unchanged drug/metabolite M1
Urinary excretion
Unchanged drug/metabolite M1, excretion rate
Pharmacokinetic parameters
Cmax, AUC, Tmax, T1/2, etc.
Secondary Outcomes
No secondary outcomes reported
Investigators
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