Status:
UNKNOWN
Nalbuphine ER Effects of Liver Disease on Pharmacokinetics and Itch
Lead Sponsor:
Trevi Therapeutics
Collaborating Sponsors:
Syneos Health
Conditions:
Nalbuphine
Hepatic Impairment
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This research study will evaluate the effect of liver disease on the pharmacokinetics (the breakdown of the drug in the body) of parallel-group, multiple oral doses nalbuphine extended release (NAL ER...
Detailed Description
The study is a three-center study that will include both a single-ascending-dose (SAD) portion and a multiple-ascending dose (MAD) portion. The PK, safety, and tolerability of single ascending doses (...
Eligibility Criteria
Inclusion
- For Subjects with Hepatic Impairment (Cohort 1 to 4 and Cohort 6)
- Male or female with stable hepatic impairment, non-smoker and/or light smoker.
- Clinical diagnosis of liver cirrhosis
- Stable for study participation based upon medical history, physical examination, vital signs, ECGs, and screening clinical laboratory evaluations
- For Healthy Subjects (Cohort 5):
- Male or female, non-smoker and/or light smoker (up to 5 cigarettes or equivalent/day),
- Healthy as defined by:
- Normal hepatic function
- The absence of clinically significant illness and surgery within 4 weeks prior to dosing.
Exclusion
- For Subjects with Hepatic Impairment (Cohort 1 to 4 and Cohort 6)
- Clinically significant unstable medical conditions
- Clinically significant abnormalities of laboratory, ECG, pulse oximetry, or clinical data that would preclude participation in the study.
- History of any illness that might confound the results of the study or pose an additional risk to the subject by participation in the study.
- Exclusion Criteria
- For Healthy Subjects (Cohort 5):
- Diagnosis of liver disease
- History of heart problems.
- History of significant alcohol abuse or drug abuse
Key Trial Info
Start Date :
October 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04020016
Start Date
October 24 2018
End Date
December 1 2020
Last Update
October 6 2020
Active Locations (3)
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1
01
Miami, Florida, United States, 33136
2
02
Miami, Florida, United States, 33146
3
03
Orlando, Florida, United States, 32809