Effect of ONC201 on participants with renal impairment
- Conditions
- CancerSolid TumoursCancer - Any cancerRenal ImpairmentRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12622000405718
- Lead Sponsor
- Chimerix, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 16
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
(± 10 years), and BMI (± 20%).
8. Blood pressure between 70 and 150 mmHg systolic (inclusive) and not higher than
90 mmHg diastolic.
Renal Impairment:
1. eGFR less than 30 mL/min
2. No clinically significant change in disease status within the last 30 days before screening,
3. Conditions consistent with renal impairment and associated symptoms a
4.. If diabetic, disease must be under control
5.. Blood pressure between 70 and 160 mmHg systolic (inclusive) and not higher than
100 mmHg diastolic.
6. Concomitant medications to treat underlying disease states or medical conditions
associated with renal impairment are allowed. Stable doses of medications for at least
2 weeks prior to dosing and throughout the study are required
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,
9. Have a history of a gastrointestinal condition or disorder that could interfere with the
absorption of the study drug
10. Have a history of hematological disorders, including disorders such as a bleeding
disorder or a risk of gastrointestinal bleeding.
11. Have a history of chronic liver disease or hepatic impairment,
12. Total bilirubin greater than the upper limit of the normal reference range at screening or
on Day -1.
13. Have symptoms of acute infection within 2 weeks prior to Day 1.
14. Have a clinically significant history of difficulty with blood donation
16. 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.
17. Have a history of clinically relevant drug or alcohol abuse or dependence
18. Have consumed grapefruit, pomegranate, or fruit juice within 3 days prior to Day 1,
19.. History of clinically significant renal illness or abnormalities.
20. 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
21. 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,
22. Have a history or symptoms of cardiovascular disease,
Subjects with Renal Impairment
1. History of renal transplant
2. 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.
3. Significant bleeding disorders that could preclude multiple venipuncture procedures
4. Paracetamol > 1 g/day within 2 weeks of dosing.
5. Clinically significant vital sign abnormalities at screening or Day -1.
6.. Clinically significant physical, laboratory, or ECG findings apart from those related to impaired renal function or underlying disease .
Subjects with Normal Renal Function
7. History of clinically significant renal illness or abnormalities.
8. 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.
9. 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.
10. Have a history or symptoms of cardiovascular disease, including bu
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the effect of severe renal impairment on ONC201 plasma PK following a single 375 mg dose of ONC201 administered orally[Plasma ONC201 PK parameters: AUCinf, Cmax, Tmax,<br>AUClast, %AUCextrap, t1/2, CL/F, Vz/F measured at the following timepoints: Predose (within 15 minutes prior to dosing) and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4,<br>6, 8, 10, 12, 14, 16, 24, 36, 48, 72, and 168 hours post dose.]
- Secondary Outcome Measures
Name Time Method