Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2018 |
| Start Date: | November 16, 2015 |
| End Date: | October 25, 2017 |
A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Entospletinib in Subjects With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib
(ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function
(stratified by smoking status, as appropriate) relative to matched, healthy controls.
(ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function
(stratified by smoking status, as appropriate) relative to matched, healthy controls.
Key Inclusion Criteria:
- Calculated body mass index from 18 to 40 kg/m^2
- Not pregnant
- Normal electrocardiogram
- Participants with impaired liver function must be sufficiently healthy based upon
medical history and physical examination, vital signs, and screening laboratory
evaluations.
Key Exclusion Criteria:
- Participation in another clinical study (current or within last 30 days)
- HIV, hepatitis B virus, or active hepatitis C virus infection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
5
sites
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
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