Effect of ONC201 on participants with renal impairment

Exclusion Criteria52

• Healthy volunteers:
• 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.
• If female, is lactating.
• Have a positive pregnancy test at screening or Day -1.
• Have received any investigational drug, agent, or device within 30 days prior to Day 1, or
• current participation in another investigational study.
• Have a positive serological test result at the screening evaluation consistent with possible infection with HBV, HCV, or HIV.
• Have a positive test for drugs of abuse and/or alcohol at either the screening or Day -1.
• Current history of heavy tobacco/nicotine use.
• Have any serious or active medical or psychiatric illness,
• Have a history of a gastrointestinal condition or disorder that could interfere with the
• absorption of the study drug
• Have a history of hematological disorders, including disorders such as a bleeding
• disorder or a risk of gastrointestinal bleeding.
• Have a history of chronic liver disease or hepatic impairment,
• Total bilirubin greater than the upper limit of the normal reference range at screening or
• on Day -1.
• Have symptoms of acute infection within 2 weeks prior to Day 1.
• Have a clinically significant history of difficulty with blood donation
• Have donated a unit of blood or had clinically significant blood loss within 30 days prior
• to Day 1 or donated plasma within 7 days prior to Day 1.
• Have a history of clinically relevant drug or alcohol abuse or dependence
• Have consumed grapefruit, pomegranate, or fruit juice within 3 days prior to Day 1,
• History of clinically significant renal illness or abnormalities.
• Have received any medication or herbal product known to induce or inhibit hepatic metabolizing enzymes within 30 days or 5 half-lives of the compound
• Have received any prescription medication, vaccines (including COVID vaccination), or
• any nonprescription medication (including vitamins and herbal products) within 14 days
• prior to Day 1,
• Have a history or symptoms of cardiovascular disease,
• Subjects with Renal Impairment
• History of renal transplant
• Acute or exacerbating renal disease OR fluctuating or deteriorating renal function as
• indicated by widely varying or worsening signs of renal impairment within 4 weeks of
• screening.
• Significant bleeding disorders that could preclude multiple venipuncture procedures
• Paracetamol > 1 g/day within 2 weeks of dosing.
• Clinically significant vital sign abnormalities at screening or Day -1.
• Clinically significant physical, laboratory, or ECG findings apart from those related to impaired renal function or underlying disease .
• Subjects with Normal Renal Function
• History of clinically significant renal illness or abnormalities.
• Have received any medication or herbal product (e.g., St. John’s wort) known to induce
• or inhibit hepatic metabolizing enzymes and/or transporters within 30 days or 5 half-lives
• of the compound, whichever is longer, prior to Day 1.
• Have received any prescription medication, vaccines (including COVID vaccination), or
• any nonprescription medication (including vitamins and herbal products) within 14 days
• or 5 half-lives of the compound, whichever is longer, prior to Day 1, unless approval is
• granted by both the investigator and the sponsor.
• Have a history or symptoms of cardiovascular disease, including but not limited to
• coronary artery disease, hypertension, congestive heart disease, and clinically significant
• cardiac arrhythmia or conduction disorder, or an abnormal ECG thought to be potentially
• clinically significant per the investigator at screening or Day -1, or QTcF > 450 ms for
• males and > 470 ms for females.