A phase 1, first-in-human study to asses the pharmacokinetics of single oral doses of JNT-517 in the fasted and fed states and to evaluate the comparative bioavailability of 2 formulations of JNT-517 in healthy participants.

Overview

No summary available.

Registry

who.int

Start Date

September 28, 2022

End Date

February 21, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Males and females 18 to 55 years of age, inclusive.
•2\. Medically healthy with no clinically significant medical history, physical examination, laboratory results, vital signs, or ECGs at Screening and Day 1\.
•3\. Body mass index (BMI) of 18\-40 kg/m2 and total body weight \>50 kg.
•4\. Non\-smoker for at least 2 weeks prior to dosing and willing to abstain during the study.
•5\. Females of childbearing potential involved in any sexual intercourse that could lead to pregnancy: the participant must agree to use two highly effective contraceptive methods from Screening until at least 1 week after the last study drug administration.
•a. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test by Day 1\.
•6\. Females not of childbearing potential or postmenopausal defined as follows:
•a. Have had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
•b. Have had amenorrhea for minimum of 1 year with confirmation by levels of follicle stimulating hormone testing
•7\. For male participants involved in any sexual intercourse that could lead to pregnancy, participant must agree to use highly effective contraceptive methods from Day 1 until at least 12 weeks after the last study drug administration.

•1\. Any acute or chronic medical condition that would prevent the participant from complying with the procedures or place the participant at risk if they participate in the study.
•2\. Positive for hepatitis B or C or human immunodeficiency virus.
•3\. Any history of malignancy in the last 5 years, excluding non\-melanoma skin cancer.
•4\. Any history of liver disease.
•5\. Any surgical or medical conditions that may affect study drug absorption, distribution, metabolism, or excretion.
•6\. Creatinine clearance \<90 mL/min by Cockcroft\-Gault formula.
•7\. Participation in another investigational drug trial within 30 days or, if known, 5 half\-lives of the investigational drug (whichever is longer).
•8\. Alcohol consumption within 5 days of randomization and/or unwilling to abstain during the study.
•9\. Use of any medications that are inhibitors or inducers of cytochrome P450 (CYP)3A4 or inhibitors of the transporter P\-glycoprotein (P\-gp) within 4 weeks prior to randomization and unwilling and/or unable to avoid these medications throughout the treatment duration.
•10\. Use of any medication that is a substrate of CYP3A4, or a substrate of the transporters P\-gp, breast cancer resistance protein (BCRP), organic anion transporter 3 (OAT3\), multidrug and toxin extrusion (MATE)1, or MATE2\-K within 4 weeks prior to randomization and unwilling and/or unable to avoid these medications throughout the treatment duration.