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

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ClinicalTrials.gov Identifier: NCT01323855
Recruitment Status : Completed
First Posted : March 28, 2011
Results First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Preladenant Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal Impairment
Study Start Date : March 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    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

  2. AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls [ Time Frame: Pre-dose to 48 hours post-dose ]
    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

  3. AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls [ Time Frame: Pre-dose to 48 hours post-dose ]
    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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323855


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01323855     History of Changes
Other Study ID Numbers: P06512
2010-023063-18 ( EudraCT Number )
MK-3814-031 ( Other Identifier: Merck )
First Posted: March 28, 2011    Key Record Dates
Results First Posted: March 10, 2016
Last Update Posted: March 10, 2016
Last Verified: February 2016

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