A Study to Investigate the Effects of Repeated Intravenous Administration of NPC-06 on the Pharmacokinetics of Amenamevir in Japanese Healthy Adult Male Volunteers. (NPC-06-7)
A Study to Investigate the Effects of NPC-06 on the Pharmacokinetics of Amenamevir.
Takahashi Morito
Nobelpharma Co., Ltd.
NMF Kayabacho Bldg., 1-17-24, Shinkawa, Chuo-ku, Tokyo
+81-3-6670-3800
takahashi.morito@nobelpharma.co.jp
Takahashi Morito
Nobelpharma Co., Ltd.
NMF Kayabacho Bldg., 1-17-24, Shinkawa, Chuo-ku, Tokyo
+81-3-6670-3800
saito.tadamasa@nobelpharma.co.jp
Not Recruiting
Jan. 24, 2023
20
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
other
(1) Japanese healthy male volunteers.
(2) Volunteers aged 18 to <40 years at the time of informed consent.
(3) Volunteers who have received sufficient explanation to participate in the study and who have provided written informed consent based on their own free will after fully understanding of the information provided.
(1) Volunteers whose BMI is less than 18.5 or 25.0 or greater at Screening or at the examination on the previous day of the study drug administration.
(2) Volunteers whose blood pressure at rest in a supine position measured at Screening or at the examination on the previous day of the study drug administration does not meet the condition of "systolic blood pressure of 100 to 140 mmHg as well as diastolic blood pressure of 60 to 90 mmHg".
(3) Volunteers whose pulse rate at rest in a supine position measured at Screening or at the examination on the previous day of the study drug administration is less than 50 beats/min.
(4) Volunteers whose values of any of the laboratory tests, vital signs, or 12-lead electrocardiography measured at Screening or at the examination on the previous day of the study drug administration is clinically abnormal based on the judgement of the principal investigator or the sub-investigator (hereinafter, the investigators).
(5) Volunteers whose QTcF measured at Screening or at the examination on the previous day of the study drug administration exceeds 450 msec in the 12-lead electrocardiography.
(6) Volunteers who showed obvious abnormalities in the vagal reflex at blood sampling at Screening or at the examination on the previous day of the study drug administration.
(7) Volunteers whose albumin level at Screening is 4.1 g/dL or less.
(8) Volunteers who show positive at Screening in any of the tests for HBs antigen, HCV antibody, HIV antigen/antibody, or serological test for syphilis.
(9) Volunteers who have been judged by the investigators to have alcohol dependence or drug dependence or a history thereof at Screening.
(10) Volunteers with renal, hepatic, cardiac, pulmonary, cerebral, ocular, gastrointestinal, hematologic, endocrine, metabolic, or psychiatric diseases, or those with a history of such diseases that the investigators judged to be inappropriate for participation in the study.
(11) Volunteers with a history of disease or surgery that may affect the absorption of the study drug (test drug or designated concomitant drug).
(12) Volunteers who have drug allergy or past history.
(13) Volunteers who are unable to maintain smoking cessation during hospitalization.
(14) Volunteers who received NPC-06 or other investigational products during the period of 16 weeks prior to the study drug administration or those of whom observations have not been completed by the date of obtaining informed consent.
(15) Volunteers who have been hospitalized or treated for surgery within 12 weeks prior to the study drug administration.
(16) Volunteers who received any medication within 4 weeks prior to the study drug administration. However, those who received medications including topical disinfectants, eye drops, vitamins that may not affect the evaluation will be allowed.
(17) Volunteers who ingested grapefruit, St. John's wort, or any food or beverage containing those components within 7 days prior to the study drug administration.
(18) Volunteers who donated blood components within 2 weeks, or who collected blood at least 200 mL within 4 weeks, or at least 400 mL within 12 weeks prior to the study drug administration.
(19) Volunteers who are unable to give appropriate contraception in accordance with the instructions of the investigators, during the period from after obtaining informed consent to the completion of the follow-up examination.
(20) Other volunteers who deemed inappropriate for participation in the study by the investigators
18age old over
40age old not
Male
pain associated with acute herpes zoster
(1) Test drug:NPC-06
NPC-06 will be intravenously administered (by drip infusion) once daily for 7 days from Day3 through Day9 (Period 2:the concomitant administration period with amenamevir) as follows:
Initial dose (Day3)
<Dose> A dose of 18 mg/kg will be administered. However, the maximum dose of the test drug should not exceed 1,200 mg as fosphenytoin sodium.
Maintenance dose (Day4 to Day9)
<Dose> A dose of 7.5 mg/kg will be administered once daily. However, the maximum dose of the test drug should not exceed 500 mg as fosphenytoin sodium.
(2) Designated concomitant drug: Amenamevir
Amenamevir will be orally administered in a total of 5 single doses on Day1 in Period 1 of amenaemvir alone period, and each on Day3, Day5, Day7 and Day9 in Period 2 of concomitant administration period with NPC-06.
<Dose> 400 mg
The pharmacokinetic profiles of the following parameters will be examined.
(1) Plasma amenamevir concentrations
(2) Plasma total fosphenytoin concentration, plasma free fosphenytoin concentration, plasma total phenytoin concentration, and plasma free phenytoin concentration.
Nobelpharma Co., Ltd.
Medical Corporation Shinanokai Shinanozaka clinic Institutional Review Board
Yotsuya Medical Building, 20 Samoncho, Shinjuku-ku, Tokyo, Tokyo
