A Phase 1 study to evaluate the effect of renal impairment on the pharmacokinetics of ONC201

Chimerix, Inc.0 sites16 target enrollmentMarch 9, 2022

Overview

No summary available.

Registry

who.int

Start Date

March 9, 2022

End Date

May 12, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Healthy Volunteers:
•1\. Male or female between 18 to 75 years of age.
•2\. Females: non\-childbearing potential
•3\. Males: surgically sterilized OR agree to use an acceptable method(s) of contraception
•during heterosexual intercourse.
•4\. Males to refrain from sperm donation during the study and for at least 90 days
•after study drug administration.
•5\. Weight at least 50 kg and a body mass index from 18 to 40 kg/m2\.
•6\. Normal renal function as defined by eGFR greater than or equal to 90 mL/min
•7\. Similar demography to a subject enrolled with severe renal impairment for sex, age

•Healthy volunteers:
•1\. If male, have a female partner who is pregnant or planning to become pregnant during the study or within 90 days after study drug administration.
•2\. If female, is lactating.
•3\. Have a positive pregnancy test at screening or Day \-1\.
•4\. Have received any investigational drug, agent, or device within 30 days prior to Day 1, or
•current participation in another investigational study.
•5\. Have a positive serological test result at the screening evaluation consistent with possible infection with HBV, HCV, or HIV.
•6\. Have a positive test for drugs of abuse and/or alcohol at either the screening or Day \-1\.
•7\. Current history of heavy tobacco/nicotine use.
•8\. Have any serious or active medical or psychiatric illness,