Investigating the safety and tolerability of ONC201 in healthy adults under fasting and fed conditions

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 18

Inclusion Criteria

1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions in this protocol.
2. Male or female between 18 to 55 years of age.
3. Female must be of non-childbearing potential i.e., postmenopausal woman or a premenopausal woman documented as surgically sterile following either a hysterectomy and/or bilateral oophorectomy, tubal ligation or placement of bilateral fallopian tube occlusion, or with medically documented ovarian failure.
4. Males must be surgically sterilized OR must agree to use an acceptable method(s) of contraception during heterosexual intercourse with a female partner capable of becoming pregnant while enrolled in the study
5. Males must agree to refrain from sperm donation during the study and for at least 90 days after study drug administration.
6. Body mass index from 18 to 32 kg/m2, inclusive.
7. Participants who are overtly healthy as determined by medical evaluation and judgment of the investigator including medical history, Physical Exam, laboratory tests, vital signs, and cardiac monitoring.

Exclusion Criteria

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.Have received any investigational drug, agent, or device within 30 days prior to Day 1, or current participation in another investigational study.
3. Have a positive result for Hepatitis B/C or HIV.
4. Have a positive test for drugs of abuse, cotinine, and/or alcohol
5. Current history of heavy tobacco/nicotine use.
6. Any serious or active medical or psychiatric illness, which could interfere with participant treatment, assessment, or compliance with the protocol.
7. Have a history of a gastrointestinal condition that could interfere with the absorption of the study drug
8. Have a history or symptoms of cardiovascular disease, including but not limited to coronary artery disease, hypertension, congestive heart disease.
9. Have a history of hematological disorders, including disorders such as a bleeding disorder or a risk of gastrointestinal bleeding.
10. Have a history of chronic liver disease or hepatic impairment,
11. Total bilirubin greater than the upper limit of the normal reference range at screening or on Period 1 Day -1.
12. Have symptoms of acute infection within 2 weeks prior to Period 1 Day 1.
13. Have clinically significant abnormal hemoglobin as determined by the investigator at the screening evaluation
14. Have donated a unit of blood or had clinically significant blood loss within 30 days prior to Period 1 Day 1 or donated plasma within 7 days prior to Period 1 Day 1.
15. Have received any prescription medication, vaccines, or any nonprescription medication (including vitamins and herbal products) within 14 days prior to Period 1 Day 1,

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Investigating the safety and tolerability of ONC201 in healthy adults - Part A

CompletedPhase 1

Chimerix, Inc.

Updated 8/9/2022