A Study to Investigate the Effects of NPC-06 on the Pharmacokinetics of Amenamevir.

Phase 1

• Conditions: pain associated with acute herpes zoster

• Registration Number: JPRN-jRCT2031220593
• Lead Sponsor: Takahashi Morito

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

(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.

Exclusion Criteria

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified