ISRCTN38890848Active, not recruitingPhase 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 enrollmentStarted: November 12, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 32
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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