A Study to Assess Pharmacokinetics (PK) of SCH 420814 in Subjects With Chronic Renal Impairment (P06512-AM1)

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: October 25, 2013
Last verified: October 2013
  Purpose

This is a two part study to compare the pharmacokinetics (PK) of SCH 420814 administered to participants with chronic renal impairment (CRI) to the PK of SCH 420814 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.


Condition Intervention Phase
Parkinson Disease
Drug: SCH 420814
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 SCH 420814 in Participants With Chronic Renal Impairment (P06512)

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 after single dosing (AUC0-∞) [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

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: Participants with Severe Renal Impairment
Severe CRI defined as creatinine clearance of <30 mL/min/1.73 m^2
Drug: SCH 420814
Single 5 mg dose, (1 x 5 mg tablet) administered orally
Other Name: Preladenant
Experimental: Participants with Moderate Renal Impairment
Moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2
Drug: SCH 420814
Single 5 mg dose, (1 x 5 mg tablet) administered orally
Other Name: Preladenant
Experimental: Participants with Mild Renal Impairment
Mild CRI defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2
Drug: SCH 420814
Single 5 mg dose, (1 x 5 mg tablet) administered orally
Other Name: Preladenant
Experimental: Participants with Normal Renal Function
Normal renal function defined as creatinine clearance of >80 mL/min/1.73 m^2
Drug: SCH 420814
Single 5 mg dose, (1 x 5 mg tablet) administered orally
Other Name: Preladenant

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
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 chronic renal impairment (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:

  • Female subjects 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 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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01323855     History of Changes
Other Study ID Numbers: P06512, 2010-023063-18
Study First Received: March 24, 2011
Last Updated: October 25, 2013
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 August 21, 2014