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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023063-18 | EudraCT Number | ||
| MK-3814-031 | Other Identifier | Merck |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Severe Renal Impairment | Experimental | 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 |
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| Part 2: Moderate Renal Impairment | Experimental | 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 |
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| Part 2: Mild Renal Impairment | Experimental | 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 |
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| Part 1: Normal Renal Function | Experimental | 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 |
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| Part 2: Normal Renal Function | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preladenant | Drug | After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | Pre-dose to 48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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Male or female adults with different degrees of renal impairment along with matched healthy adults with normal renal function were selected for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Severe Renal Impairment | Participants with severe chronic renal impairment (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 |
| FG001 | Part 2: Moderate Renal Impairment | 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 |
| FG002 | Part 2: Mild Renal Impairment | 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 |
| FG003 | Part 1: Normal Renal Function | 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 |
| FG004 | Part 2: Normal Renal Function | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Severe Renal Impairment | 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 |
| BG001 | Part 2: Moderate Renal Impairment |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | Four participants with severe CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with severe CRI are presented, participants with mild or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure | Posted | Geometric Mean | 95% Confidence Interval | ng.hr/mL | Pre-dose to 48 hours post-dose |
|
Up to Day 7
All enrolled participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Severe Renal Impairment | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C539997 | 2-(2-furanyl)-7-(2-(4-(4-(2-methoxyethoxy)phenyl)-1-piperazinyl)ethyl)-7H-pyrazolo(4,3-e)(1,2,4)triazolo(1,5-c)pyrimidine-5-amine |
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|
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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 |
| BG002 | Part 2: Mild Renal Impairment | 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 |
| BG003 | Part 1: Normal Renal Function | 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 |
| BG004 | Part 2: Normal Renal Function | 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 |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Part 2: Moderate Renal Impairment | 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 |
| OG002 | Part 2: Mild Renal Impairment | 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 |
| OG003 | Part 1: Normal Renal Function | 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 |
| OG004 | Part 2: Normal Renal Function | 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 |
|
|
|
| Primary | 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 | One participant with moderate CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with moderate CRI are presented, participants with mild or severe CRI or their corresponding healthy matched controls were not analyzed in this outcome measure | Posted | Geometric Mean | 95% Confidence Interval | ng.hr/mL | Pre-dose to 48 hours post-dose |
|
|
|
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| Primary | 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 | One participant with mild CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with mild CRI are presented, participants with severe or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure | Posted | Geometric Mean | 95% Confidence Interval | ng.hr/mL | Pre-dose to 48 hours post-dose |
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|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Part 2: Moderate Renal Impairment | 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 | 0 | 9 | 0 | 9 |
| EG002 | Part 2: Mild Renal Impairment | 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 | 0 | 8 | 1 | 8 |
| EG003 | Part 1: Normal Renal Function | 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 | 0 | 9 | 0 | 9 |
| EG004 | Part 2: Normal Renal Function | 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 | 0 | 11 | 0 | 11 |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
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The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |