Parkinson DiseasePhase 1NCT01323855

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

A Phase 1 study testing Preladenant in people with Parkinson Disease, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson Disease
What is being tested?: Preladenant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: No sites listed yet
Study dates: 28 Mar 2011to 29 Nov 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

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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

About this study

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

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
Being tested: Preladenant
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PreladenantDrug
Also called SCH 420814
After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally

Study groups in NCT01323855
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Preladenant

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: Pre-dose to 48 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 201129 Nov 2011

First posted28 Mar 2011 (estimated)
Study start28 Mar 2011
Primary completion29 Nov 2011
Study completion29 Nov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01323855
Sponsor's protocol ID: P06512
Other IDs: 2010-023063-18, MK-3814-031
Status last verified: Sep 2018
First submitted: 24 Mar 2011
Last updated: 2 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal Impairment
ClinicalTrials.gov ID: NCT01323855
Acronym / sponsor ID: P06512
Conditions: Parkinson Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 28 Mar 2011 (actual)
Primary completion: 29 Nov 2011 (actual)
Study completion: 29 Nov 2011 (actual)
First posted: 28 Mar 2011 (estimated)
Results: Posted 10 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Part 1: Severe Renal Impairment	Experimental	Drug: PreladenantParticipants 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
Part 2: Moderate Renal Impairment	Experimental	Drug: PreladenantParticipants 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
Part 2: Mild Renal Impairment	Experimental	Drug: PreladenantParticipants 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
Part 1: Normal Renal Function	Experimental	Drug: PreladenantParticipants 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
Part 2: Normal Renal Function	Experimental	Drug: PreladenantParticipants 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

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PreladenantAlso: SCH 420814After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally	Drug	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

Primary outcome

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
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
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

Results and safety

Results posted to the registry on 10 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Severe Renal Impairment	9	9
Part 2: Moderate Renal Impairment	9	9
Part 2: Mild Renal Impairment	8	8
Part 1: Normal Renal Function	9	9
Part 2: Normal Renal Function	11	11

Primary outcome: 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. Geometric mean (95% Confidence Interval). Unit: ng.hr/mL

Measure	Part 1: Severe Renal Impairment n = 5	Part 2: Moderate Renal Impairment n = 0	Part 2: Mild Renal Impairment n = 0	Part 1: Normal Renal Function n = 7	Part 2: Normal Renal Function n = 0
Value	160.53 (81.13 to 317.62)	–	–	135.12 (77.83 to 234.56)	–

Part 1: Severe Renal Impairment vs Part 1: Normal Renal Function: GMR: 1.19 (90% CI 0.54 to 2.62)

Population analysed: Four participants with severe CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with severe CRI are presented, participants with mild or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure

Primary outcome: AUC0-∞ After Single Dosing With Preladenant for Participants With Moderate CRI Versus Healthy Matched Controls

Time frame: Pre-dose to 48 hours post-dose. Geometric mean (95% Confidence Interval). Unit: ng.hr/mL

Measure	Part 1: Severe Renal Impairment n = 0	Part 2: Moderate Renal Impairment n = 8	Part 2: Mild Renal Impairment n = 0	Part 1: Normal Renal Function n = 0	Part 2: Normal Renal Function n = 5
Value	–	197.43 (99.12 to 393.25)	–	–	152.18 (67.65 to 342.34)

Part 2: Moderate Renal Impairment vs Part 2: Normal Renal Function: GMR: 1.30 (90% CI 0.59 to 2.87)

Population analysed: One participant with moderate CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with moderate CRI are presented, participants with mild or severe CRI or their corresponding healthy matched controls were not analyzed in this outcome measure

Primary outcome: AUC0-∞ After Single Dosing With Preladenant for Participants With Mild CRI Versus Healthy Matched Controls

Time frame: Pre-dose to 48 hours post-dose. Geometric mean (95% Confidence Interval). Unit: ng.hr/mL

Measure	Part 1: Severe Renal Impairment n = 0	Part 2: Moderate Renal Impairment n = 0	Part 2: Mild Renal Impairment n = 7	Part 1: Normal Renal Function n = 0	Part 2: Normal Renal Function n = 4
Value	–	–	275.50 (183.51 to 413.61)	–	104.66 (65.54 to 167.15)

Part 2: Mild Renal Impairment vs Part 2: Normal Renal Function: GMR: 2.63 (90% CI 1.38 to 5.04)

Population analysed: One participant with mild CRI, and two matched healthy participants with insufficient terminal phase data to allow adequate characterization, were not analyzed. As only participants with mild CRI are presented, participants with severe or moderate CRI or their corresponding healthy matched controls were not analyzed in this outcome measure

Adverse events

Time frame: Up to Day 7. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Severe Renal Impairment	0 of 9 (0%)	0 of 9 (0%)	Not reported
Part 2: Moderate Renal Impairment	0 of 9 (0%)	0 of 9 (0%)	Not reported
Part 2: Mild Renal Impairment	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
Part 1: Normal Renal Function	0 of 9 (0%)	0 of 9 (0%)	Not reported
Part 2: Normal Renal Function	0 of 11 (0%)	0 of 11 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Preladenant in people with Parkinson Disease, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01323855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.