None listed
Conditions
Brief summary
ONC201 is an investigational drug being developed to treat high grade glioma (a type of brain cancer). “Investigational” means that the FDA (the U.S. Food and Drug Administration) has not approved ONC201 as a treatment for this condition. ONC201 is a newly discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to use a new way to kill brain tumor cells but not normal cells. The study sponsors need to know how the drug works in healthy adults to compare this with when the drug is taken in cancer patients. Part B1 will compare 3 doses (treatment periods) of ONC201 administered as a capsule, and a capsule sprinkled on applesauce and a capsule mixed with an extemporaneous liquid like Ora-Sweet. It is envisaged that 18 participants will be recruited in Part B1. Please see linked trials. In each treatment period, ONC201 will be administered on Day 1. Participants will be admitted to the clinic on the day prior to dosing, and remain in the clinic until discharged on the morning of Day 3 following completion of all scheduled study procedures and assessments. Safety will be assessed through the reporting of AEs, Physical and Neurological Examinations, vital signs measurements, ECGs and clinical laboratory results.
Interventions
Part B1 - participants will randomly receive each of the following single-dose treatments,in a randomised sequence, over the course of 3 treatment periods with a washout interval between doses of at least 7 days:
• Treatment A: 125 mg single dose of ONC201 administered as one intact 125 mg capsule under a fasting condition (nothing but water for at least 10 hours prior to dosing).
• Treatment B: 125 mg single dose of ONC201 administered as the contents of one 125 mg capsule sprinkled on and st
Part B1 - participants will randomly receive each of the following single-dose treatments,in a randomised sequence, over the course of 3 treatment periods with a washout interval between doses of at least 7 days: • Treatment A: 125 mg single dose of ONC201 administered as one intact 125 mg capsule under a fasting condition (nothing but water for at least 10 hours prior to dosing). • Treatment B: 125 mg single dose of ONC201 administered as the contents of one 125 mg capsule sprinkled on and stirred onto 12mls applesauce (nothing but water for at least 10 hours prior to dosing). • Treatment C: 125 mg single dose of ONC201 administered as the contents of one 125 mg capsule mixed with 12mls of an extemporaneous compounding liquid (e.g., Ora-Sweet) (nothing but water for at least 10 hours prior to dosing). All doses will be administered in the clinic. A randomisation code is provided and participants will be allocated a treatment sequence once deemed eligible for randomisation.
Sponsors
Chimerix, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
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,
Outcome results
None listed