Phase 1
N=42
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
Chronic Hepatic Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01465412 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant — 97.864; 91.014; 300.667; 115.715 hr*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Preladenant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant |
97.864; 91.014; 300.667; 115.715 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Preladenant After a Single Dose of Preladenant |
39.380; 30.171; 56.997; 39.735 | — |
| SECONDARY AUC 0-t of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant |
28.505; 15.395; 60.486; 25.288 | — |
| SECONDARY Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant |
10.503; 6.784; 13.983; 9.936 | — |
| SECONDARY AUC 0-t of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant |
38.262; 24.612; 170.215; 35.421 | — |
| SECONDARY Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant |
12.691; 10.004; 21.761; 10.993 | — |
| SECONDARY AUC 0-t of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant |
1.605; 1.211; 6.792; 1.681 | — |
| SECONDARY Cmax of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant |
0.646; 0.401; 1.288; 0.577 | — |
Summary
The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers. Part 1 of this study compares healthy volunteers with participants with mild hepatic impairment. Part 2 compares healthy volunteers with participants with moderate hepatic impairment. Healthy volunteers in each part of this study are to be matched with participants with hepatic impairment by race, age, gender, and body mass index (BMI). The primary hypotheses are that in participants with mild or moderate HI, the area under the concentration-time curve from time 0 extrapolated to time of the last quantifiable concentration (AUC0-t) of preladenant is similar to that observed in matched healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within the interval [0.50, 2.00].
Eligibility Criteria
Key Inclusion Criteria for Healthy Participants Groups:
- Must be healthy with normal hepatic function and be free of any clinically significant disease or condition that requires a physician's care and/or would interfere with study evaluations or procedures.
Key Inclusion Criteria for Hepatic Impaired Groups:
- Must have mild or moderate hepatic impairment.
- Must have a diagnosis of chronic liver disease for >6 months.
- Clinical laboratory tests, physical examination, and electrocardiographs must be clinically acceptable to the investigator and sponsor.
- Must be free, other than chronic liver disease, of significant medical conditions unrelated to their hepatic disorder except for conditions that in the opinion of the investigator may not interfere with the study evaluations, procedures or participation.
Key Exclusion Criteria
- Must not be on any prohibited medications for entry into the trial.
Data sourced from ClinicalTrials.gov (NCT01465412). 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.