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Clinical Trials/ACTRN12622000405718
ACTRN12622000405718CompletedPhase 1

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

Chimerix, Inc.0 sites16 target enrollmentStarted: March 9, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
16
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Treatment
Masking
Open (masking not used)

Eligibility Criteria

Ages
18 Years to 75 Years (—)
Sex
All

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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
  • •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

Investigators

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Effect of ONC201 on participants with... | Clinical Trial