Clinical trial · Interventional
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Entospletinib in Subjects With Normal and Impaired Hepatic Function
NCT02521376CI-TRIAL-00039758completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entospletinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1 (Moderate Hepatic Impairment)
- description
- Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.
- interventionNames
- Drug: Entospletinib
- type
- EXPERIMENTAL
- label
- Cohort 2 (Severe Hepatic Impairment)
- description
- Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.
- interventionNames
- Drug: Entospletinib
- type
- EXPERIMENTAL
- label
- Cohort 3 (Mild Hepatic Impairment)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.