ISRCTN38890848
Active, not recruiting
Phase 1
A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Pralsetinib in Subjects With Moderate or Severe Hepatic Impairment Compared to Healthy Subjects
Roche (United States)0 sites32 target enrollmentNovember 12, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hepatic impairment
- Sponsor
- Roche (United States)
- Enrollment
- 32
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males or females of non\-childbearing potential, between 18 and 74 years of age, inclusive
- •2\. Normal hepatic function, moderate hepatic impairment, or severe hepatic impairment based on the Child\-Pugh classification
Exclusion Criteria
- •1\. History of surgical or artificial shunts (i.e., transjugular intrahepatic portosystemic procedure)
- •2\. QT interval corrected using Fridericia’s formula \>480 ms demonstrated on at least two ECGs that are performed \>30 minutes apart or history or presence of an abnormal ECG, which, in the investigator’s opinion, is clinically significant
- •3\. History of alcoholism or drug addiction within 1 year prior to Check\-in (Day \-1\)
- •4\. Use of oral antibiotics to treat an active infection within 4 weeks or intravenous antibiotics to treat an active infection within 8 weeks prior to Screening
- •5\. Prior exposure to pralsetinib or other RET kinase inhibitor within 30 days prior to Check\-in
Outcomes
Primary Outcomes
Not specified
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