A Phase 1 interventional study of Preladenant in Parkinson Disease, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 46 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Exclusion Criteria:
Participants with severe CRI, defined as creatinine clearance of \<30 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Drug: Preladenant
Participants with moderate CRI defined as creatinine clearance of ≥30 and \<50 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Drug: Preladenant
Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Drug: Preladenant
Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Drug: Preladenant
Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Drug: Preladenant
After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally
Also known as: SCH 420814
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
Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
Time frame: Pre-dose to 48 hours post-dose
AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls
Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
Time frame: Pre-dose to 48 hours post-dose
AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls
Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
Time frame: Pre-dose to 48 hours post-dose
Male or female adults with different degrees of renal impairment along with matched healthy adults with normal renal function were selected for this study.
| Milestone | Part 1: Severe Renal Impairment | Part 2: Moderate Renal Impairment | Part 2: Mild Renal Impairment | Part 1: Normal Renal Function | Part 2: Normal Renal Function |
|---|---|---|---|---|---|
| Started | 9 | 9 | 8 | 9 | 11 |
| Completed | 9 | 9 | 8 | 9 | 11 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
| ng.hr/mL | Part 1: Severe Renal Impairment | Part 2: Moderate Renal Impairment | Part 2: Mild Renal Impairment | Part 1: Normal Renal Function | Part 2: Normal Renal Function |
|---|---|---|---|---|---|
| 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 (81.13 to 317.62) | — | — | 135.12 (77.83 to 234.56) | — |
Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
| ng.hr/mL | Part 1: Severe Renal Impairment | Part 2: Moderate Renal Impairment | Part 2: Mild Renal Impairment | Part 1: Normal Renal Function | Part 2: Normal Renal Function |
|---|---|---|---|---|---|
| AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls | — | 197.43 (99.12 to 393.25) | — | — | 152.18 (67.65 to 342.34) |
Blood samples were taken at the following timepoints: pre-dose, 0.25, 0.50, 0.75, 1, 2, 4, 6, 12, 16, 24, 30, 36 and 48 hours postdose in order to determine the AUC0-∞ of preladenant
| ng.hr/mL | Part 1: Severe Renal Impairment | Part 2: Moderate Renal Impairment | Part 2: Mild Renal Impairment | Part 1: Normal Renal Function | Part 2: Normal Renal Function |
|---|---|---|---|---|---|
| AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls | — | — | 275.50 (183.51 to 413.61) | — | 104.66 (65.54 to 167.15) |
Collected over Up to Day 7. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Severe Renal Impairment | — | 0/9 (0%) | 0/9 (0%) |
| Part 2: Moderate Renal Impairment | — | 0/9 (0%) | 0/9 (0%) |
| Part 2: Mild Renal Impairment | — | 0/8 (0%) | 1/8 (12.5%) |
| Part 1: Normal Renal Function | — | 0/9 (0%) | 0/9 (0%) |
| Part 2: Normal Renal Function | — | 0/11 (0%) | 0/11 (0%) |
| Event | Part 1: Severe Renal Impairment | Part 2: Moderate Renal Impairment | Part 2: Mild Renal Impairment | Part 1: Normal Renal Function | Part 2: Normal Renal Function |
|---|---|---|---|---|---|
| ALANINE AMINOTRANSFERASE INCREASEDInvestigations | 0/9 | 0/9 | 1/8 | 0/9 | 0/11 |
| GAMMA-GLUTAMYLTRANSFERASE INCREASEDInvestigations | 0/9 | 0/9 | 1/8 | 0/9 | 0/11 |
| Age, Continuous(Years) | Part 1: Severe Renal Impairment | Part 2: Moderate Renal Impairment | Part 2: Mild Renal Impairment | Part 1: Normal Renal Function | Part 2: Normal Renal Function | Total |
|---|---|---|---|---|---|---|
| Mean | 59.6 ± 12.4 | 66.9 ± 7.8 | 63.3 ± 7.6 | 59.3 ± 11.3 | 67.4 ± 4.0 | 63.5 ± 9.3 |
| Sex: Female, Male(Participants) | Part 1: Severe Renal Impairment | Part 2: Moderate Renal Impairment | Part 2: Mild Renal Impairment | Part 1: Normal Renal Function | Part 2: Normal Renal Function | Total |
|---|---|---|---|---|---|---|
| Female | 3 | 4 | 5 | 3 | 5 | 20 |
| Male | 6 | 5 | 3 | 6 | 6 | 26 |
No study locations are listed for this record.
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC