Phase 1
Completed N=56
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
Source: ClinicalTrials.gov NCT02521376 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Pharmacokinetic (PK) Parameter: AUCtau of ENTO — 1788.9; 7490.0; 4081.5; 3318.0 h*ng/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter: AUCtau of ENTO |
1788.9; 7490.0; 4081.5; 3318.0; 7036.0; 3402.7 | — |
| PRIMARY Pharmacokinetic (PK) Parameter: Cmax of ENTO |
313.1; 1007.3; 582.3; 497.4; 837.7; 521.1 | — |
| SECONDARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
14.3; 22.3; 30.0; 30.0 | — |
| SECONDARY Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities |
100.0; 88.9; 60.0; 50.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02521376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.