A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)

NCT01323855 | Completed Phase 1 Results

• 3 other identifiers: P065122010-023063-18MK-3814-031
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (5)

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

Drug: Preladenant

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

Drug: Preladenant

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

Drug: Preladenant

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

Drug: Preladenant

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

Drug: Preladenant

Interventions

Preladenant DRUG

After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally

Also known as: SCH 420814

Part 1: Normal Renal Function; Part 1: Severe Renal Impairment; Part 2: Mild Renal Impairment; Part 2: Moderate Renal Impairment; Part 2: Normal Renal Function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

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

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 28, 2011
• Study Start: March 28, 2011
• Primary Completion: November 29, 2011
• Study Completion: November 29, 2011
• Last Updated: October 2, 2018
• Results First Posted: March 10, 2016

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share