Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01323855
First received: March 24, 2011
Last updated: February 11, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Parkinson Disease
Drug: Preladenant
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal Impairment

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 [ Time Frame: Pre-dose to 48 hours post-dose ] [ Designated as safety issue: No ]
    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

  • AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls [ Time Frame: Pre-dose to 48 hours post-dose ] [ Designated as safety issue: No ]
    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

  • AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls [ Time Frame: Pre-dose to 48 hours post-dose ] [ Designated as safety issue: No ]
    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


Enrollment: 46
Study Start Date: March 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Preladenant
After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally
Other Name: SCH 420814
Experimental: 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
Drug: Preladenant
After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally
Other Name: SCH 420814
Experimental: 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
Drug: Preladenant
After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally
Other Name: SCH 420814
Experimental: 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
Drug: Preladenant
After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally
Other Name: SCH 420814
Experimental: 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
Drug: Preladenant
After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally
Other Name: SCH 420814

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323855

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01323855     History of Changes
Other Study ID Numbers: P06512  2010-023063-18  MK-3814-031 
Study First Received: March 24, 2011
Results First Received: February 11, 2016
Last Updated: February 11, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Parkinson Disease
Renal Insufficiency
Renal Insufficiency, Chronic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 28, 2016