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

Parkinson Disease Clinical Trial

Official title:

A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323855
• Other study ID #: P06512
• Secondary ID: 2010-023063-18MK
• Status: Completed
• Phase: Phase 1
• Start date: March 28, 2011
• Est. completion date: November 29, 2011

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 29, 2011
• Est. primary completion date: November 29, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-8) 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 AUC0-8 of preladenant	Pre-dose to 48 hours post-dose
Primary	AUC0-8 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 AUC0-8 of preladenant	Pre-dose to 48 hours post-dose
Primary	AUC0-8 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 AUC0-8 of preladenant	Pre-dose to 48 hours post-dose