Renal InsufficiencyPhase 1NCT01832103
The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)
A Phase 1 study testing MK-7145 in people with Renal Insufficiency, run by Merck Sharp & Dohme LLC.
Trial summary
The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of MK-7145 2 mg immediate release (IR) following single-dose administration in male participants with moderate renal insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- MK-7145
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) 18 to 35 kg/m^2
- Nonsmoker and/or have not used nicotine or nicotine-containing products
- for at least 3 months prior to enrollment
- Estimated glomerular filtration rate (eGFR) 30 to 60 mL/min/1.73 m^2
Who cannot join
- History of stroke, chronic seizures, or major neurological disorder
- Ongoing, clinically significant endocrine, gastrointestinal, cardiovascular,
- hematological, hepatic, immunological, respiratory, or genitourinary abnormalities or diseases
- Systolic blood pressure (SBP) ≤95 mmHg or >160 mmHg, or diastolic blood
- pressure (DBP) ≤45 mmHg or >95 mmHg
- History of neoplastic disease except for adequately treated non-melanomatous skin carcinoma
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- Unable to refrain from, or anticipates the use of, strong/moderate cytochrome P450 3A4 (CYP3A4) inhibitors
- Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages, wine, or distilled spirits per day
- Consumes excessive amounts of caffeine, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day
- Had major surgery or donated blood within 8 weeks prior to enrollment
- Has participated in another investigational study within 4 weeks prior
- History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food
- Currently a regular user of illicit drugs, or has a history of drug (including alcohol) abuse within approximately 6 months
- Has active or has a history of nephrolithiasis
- Has had a kidney removed or has a functioning renal transplant
About this study
Official title: A Phase I Study to Evaluate the Pharmacokinetics of MK-7145 Following Single Dose Administration in Patients With Moderate Renal Insufficiency
The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of MK-7145 2 mg immediate release (IR) following single-dose administration in male participants with moderate renal insufficiency. In addition, the study will evaluate the pharmacodynamic effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in male participants with moderate renal insufficiency.
- Conditions
- Renal Insufficiency
- Being tested
- MK-7145
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-7145Drug
| Study group | Role | What they receive |
|---|---|---|
| MK-7145 | Experimental | MK-7145 2 mg IR administered as a single oral dose. Receives: Drug: MK-7145 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma-Time Curve From 0 to Infinity (AUC0-∞) of MK-7145 2 mg IR Following Single Dose Administration
Measured: Up to 48 Hours Post Dose
Maximum Plasma Concentration (Cmax) of MK-7145 2 mg IR Following Single Dose Administration
Measured: Up to 48 Hours Post Dose
Time to Maximum Plasma Concentration (Tmax) of MK-7145 2 mg IR Following Single Dose Administration
Measured: Up to 48 Hours Post Dose
Apparent Half-Life (t 1/2) of MK-7145 2 mg IR Following Single Dose Administration
Measured: Up to 48 Hours Post Dose
Oral Clearance (CL/F) of MK-7145 2 mg IR Following Single Dose Administration
Measured: Up to 24 Hours Post Dose
Oral Volume of Distribution (V/F) of MK-7145 2 mg IR Following Single Dose Administration
Measured: Up to 48 Hours Post Dose
Secondary outcomes (1)
Change From Baseline in 24-Hr Urine Natriuresis (UNa0-24)
Measured: 24 Hours Prior to Dosing (Baseline) and Up to 24 Hours Post Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832103
- Sponsor's protocol ID
- 7145-018
- Other IDs
- 2013-000838-35
- Status last verified
- Sep 2013
- First submitted
- 11 Apr 2013
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Pharmacokinetics of MK-7145 Following Single Dose Administration in Patients With Moderate Renal Insufficiency
- ClinicalTrials.gov ID
- NCT01832103
- Acronym / sponsor ID
- 7145-018
- Conditions
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of MK-7145 2 mg immediate release (IR) following single-dose administration in male participants with moderate renal insufficiency. In addition, the study will evaluate the pharmacodynamic effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in male participants with moderate renal insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK-7145 | Experimental | Drug: MK-7145MK-7145 2 mg IR administered as a single oral dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) 18 to 35 kg/m^2
- Nonsmoker and/or have not used nicotine or nicotine-containing products
- for at least 3 months prior to enrollment
- Estimated glomerular filtration rate (eGFR) 30 to 60 mL/min/1.73 m^2
Key exclusion criteria (15 listed)
- History of stroke, chronic seizures, or major neurological disorder
- Ongoing, clinically significant endocrine, gastrointestinal, cardiovascular,
- hematological, hepatic, immunological, respiratory, or genitourinary abnormalities or diseases
- Systolic blood pressure (SBP) ≤95 mmHg or >160 mmHg, or diastolic blood
- pressure (DBP) ≤45 mmHg or >95 mmHg
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 |
|---|---|---|
| MK-7145 | Drug | MK-7145 |
Primary outcome
Area Under the Plasma-Time Curve From 0 to Infinity (AUC0-∞) of MK-7145 2 mg IR Following Single Dose Administration
Time frame: Up to 48 Hours Post Dose
Maximum Plasma Concentration (Cmax) of MK-7145 2 mg IR Following Single Dose Administration
Time frame: Up to 48 Hours Post Dose
Time to Maximum Plasma Concentration (Tmax) of MK-7145 2 mg IR Following Single Dose Administration
Time frame: Up to 48 Hours Post Dose
Apparent Half-Life (t 1/2) of MK-7145 2 mg IR Following Single Dose Administration
Time frame: Up to 48 Hours Post Dose
Oral Clearance (CL/F) of MK-7145 2 mg IR Following Single Dose Administration
Time frame: Up to 24 Hours Post Dose
Oral Volume of Distribution (V/F) of MK-7145 2 mg IR Following Single Dose Administration
Time frame: Up to 48 Hours Post Dose
1 secondary outcome
Change From Baseline in 24-Hr Urine Natriuresis (UNa0-24)
Time frame: 24 Hours Prior to Dosing (Baseline) and Up to 24 Hours Post Dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-7145 in people with Renal Insufficiency, 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 15 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: withdrawn, as of the sponsor's last update on 24 Sep 2013. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 Plasma-Time Curve From 0 to Infinity (AUC0-∞) of MK-7145 2 mg IR Following Single Dose Administration (time frame: Up to 48 Hours Post Dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2013.