A study to evaluate the processing by the body and safety of pralsetinib in participants with hepatic impairment compared to healthy participants
- Conditions
- Hepatic impairmentDigestive System
- Registration Number
- ISRCTN38890848
- Lead Sponsor
- Roche (United States)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 32
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method