Phase 1
N=46
A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT01323855 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched Controls — 160.53; 135.12 ng.hr/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
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) After Single Dosing With Preladenant for Participants With Severe CRI Versus Healthy Matched Controls |
160.53; 135.12 | — |
| PRIMARY AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls |
197.43; 152.18 | — |
| PRIMARY AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls |
275.50; 104.66 | — |
Summary
This is a two part study to compare the PK of preladenant administered to participants with CRI to the PK of preladenant administered to healthy participants. Part 1 will compare the PK of participants with severe CRI to healthy participants. Part 2 will compare the PK of participants with moderate CRI and participants with mild CRI to healthy participants. The primary hypotheses are that the plasma area under the concentration-time curve from time 0 to infinity after single dosing (AUC0-∞) of preladenant in participants with either severe, moderate or mild CRI is similar to that of matched healthy participants.
Eligibility Criteria
Inclusion Criteria
- Has a body mass index (BMI) between 19 to 34 kg/m^2, inclusive
- Has mild to severe CRI and not on dialysis (Participants with normal renal function are to be matched to subjects with renal impairment)
- Clinical laboratory tests, electrocardiogram, and vital signs within normal ranges
- Free of any clinically significant disease that would interfere with the study evaluations (except related to his/her renal disease and comorbid conditions)
Exclusion Criteria
- Females who are pregnant, intend to become pregnant (within 3 months of ending the study), or are nursing/breastfeeding
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
- Had a renal transplant or are on dialysis
- Has a history of any infectious disease within 4 weeks
- Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
- Has donated blood or had a blood transfusions in the past 60 days
- Has demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which could interfere with their ability to participate in the trial
- Has a history of malignancy
- Has evidence of suicidality or is at risk for self-harm or harm to others
Data sourced from ClinicalTrials.gov (NCT01323855). 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.