Renal ImpairmentPhase 1NCT04678505

Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)

A Phase 1 study testing MK-3402 in people with Renal Impairment, run by Merck Sharp & Dohme LLC at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402 in participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3402 is removed from the plasma by hemodialysis (HD), and evaluate the safety and tolerability of MK-3402 in… Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: MK-3402
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 2 sitesUnited States
Study dates: 10 Feb 2021to 27 Apr 2021
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

Is in good health based on medical history, physical examination, vital signs (VS) measurements, and electrocardiogram (ECG)s performed before randomization.
Is in good health based on laboratory safety tests obtained at the screening visit and before administration of the initial dose of study drug.
Has a body mass index (BMI) ≥18 kg/m2 and ≤40 kg/m2. BMI = weight (kg)/height (m)2.
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
Refrain from donating sperm
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)

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A female participant is eligible to participate if she is a woman of non-childbearing potential.
Panel A: Has a baseline estimated glomerular filtration rate (eGFR) ≥60 and <90 mL/min/1.73 m2 based on the Modification of Diet in Renal Disease (MDRD) equation.
Panel B: Has a baseline eGFR ≥30 and <60 mL/min/1.73 m2 based on the MDRD equation.
Panel C: Has a baseline eGFR ≥15 and <30 mL/min/1.73 m2 based on the MDRD equation.
Panels A, B and C: Has had no clinically significant change in renal status at least 1 month prior to dosing and is not currently receiving or has not previously been on hemodialysis (HD).
Panel D: Has an eGFR ≥90 mL/min/1.73 m2 based on the MDRD equation.
Panel E: Has end stage renal disease (ESRD) and maintained on a stable regimen of at least 3 times per week HD for at least 3 months prior to first dosing.

Who cannot join

Panels A, B, C and E: Has a history of any clinically significant concomitant disease or condition (including treatment for such conditions) or diseases whose current condition is considered clinically unstable that, in the opinion of the investigator, could either interfere with the study drug, compromise interpretation of study data, or pose an unacceptable risk to the patient.
Panel D: Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.
Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder that would impact study conduct. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator.
Has a history of cancer (malignancy).
Exceptions: (1) Adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or; (2) Other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, in the opinion of the investigator and with agreement of the Sponsor (eg, malignancies that have been successfully treated ≥10 years prior to the prestudy screening visit).
Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food.

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Is positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
Panels A, B, C and E: Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies for the prohibited time period.
Panel D: Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the poststudy visit. There may be certain medications that are permitted.
Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to study drug administration. The window will be derived from the date of the last dose of study medication in the previous study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, 32809
Prism Clinical Research, LLC ( Site 0002)
Saint Paul, Minnesota, 55114

Other trials in United States

About this study

Official title: An Open-Label Trial to Evaluate the Pharmacokinetics of MK-3402 Following Administration of a Single IV Dose to Participants With Mild, Moderate, and Severe Renal Impairment and End-Stage Renal Disease

Conditions: Renal Impairment
Being tested: MK-3402
Keywords: MK-3402
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-3402Drug
MK-3402 administered as a single dose of 100 mg IV infusion on the following dosage days:
Panels A to D: Day 1 Panel E: Day 1 in Periods 1 and 2

Study groups in NCT04678505
Study group	Role	What they receive
Panel A: Mild Renal Impairment	Experimental	Participants with mild renal impairment will receive a single dose of 100 mg MK-3402 via intravenous (IV) infusion on Day 1. Receives: Drug: MK-3402
Panel B: Moderate Renal Impairment	Experimental	Participants with moderate renal impairment will receive a single dose of 100 mg MK-3402 via IV infusion on Day 1. Receives: Drug: MK-3402
Panel C: Severe Renal Impairment	Experimental	Participants with severe renal impairment will receive a single dose of 100 mg MK-3402 via IV infusion on Day 1. Receives: Drug: MK-3402
Panel D: Healthy Participants	Experimental	Healthy matched control participants will receive a single dose of 100 mg MK-3402 via IV infusion on Day 1. Receives: Drug: MK-3402
Panel E: End-Stage Renal Disease (ESRD) Undergoing Hemodialysis	Experimental	Participants with ESRD undergoing HD will receive a single dose of 100 mg MK-3402 via IV infusion after HD on Day 1 of Period 1 and before HD on Day 1 of Period 2. There will be at least a 6-day washout period before dosing in Period 2. Receives: Drug: MK-3402

What is being measured

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

Area Under the Curve From Dosing to Infinity (AUC0-inf) of MK-3402
AUC0-inf is defined as area under the plasma concentration-time curve from dosing to infinity.
Measured: Pre-dose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Plasma Concentration at the End of Infusion (Ceoi) of MK-3402
Ceoi is defined as the amount of study drug in plasma following IV infusion administration of study drug. Plasma samples were collected at pre-specified time points and Ceoi was assessed.
Measured: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Time to Maximum Plasma Concentration (Tmax) of MK-3402
Tmax is defined as the time required for a study drug to reach maximum concentration in plasma. Plasma samples were collected at pre-specified time points and Tmax was assessed.
Measured: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Apparent Plasma Half-life (t½) of MK-3402
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak.
Measured: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Apparent Plasma Clearance (CL) of MK-3402
CL is defined as the time it takes for the study drug to be completely removed from the body's plasma.
Measured: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Volume of Distribution (Vd) of MK-3402
Vd is defined as the distributed volume of study drug in plasma.
Measured: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1

Secondary outcomes (10)

Number of Participants With Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug
Measured: Up to 15 days
Number of Participants Who Discontinued From Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug
Measured: Up to 15 days
Dialysis Clearance Based on Plasma (CLDplasma) of MK-3402
Plasma dialysis samples were to be collected at pre-specified time points to calculate CLDplasma.
Measured: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Concentration of Dialysate (CD) of MK-3402
Plasma dialysis samples were to be collected at pre-specified time points to calculate CD.
Measured: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Amount of Drug Recovered From the Dialysate From Plasma (AED) of MK-3402
Plasma dialysis samples were to be collected at pre-specified time points to calculate AED.
Measured: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Percentage of AED (% Dose) of MK-3402
Plasma dialysis samples were to be collected at pre-specified time points to calculate AED (% dose).
Measured: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion.
Hemodialysis Clearance Based on Plasma (CLD Dialysate) of MK-3402
Plasma dialysis samples were to be collected at pre-specified time points to measure CLD dialysate.
Measured: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-3402
Ae0-24 is defined as the amount of study drug unchanged in urine after 0-24 hours. Urine samples were collected at pre-specified intervals and Ae0-24 was assessed.
Measured: Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose
Fraction of Dose Recovered in Urine (Fe) of MK-3402
Fe is defined as the fraction of the dose of study drug in urine.
Measured: Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose
Renal Clearance (CLr) of MK-3402
CLr is defined as the time it takes for the study drug to be completely removed by the kidneys.
Measured: Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose

Timeline

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

10 Feb 202127 Apr 2021

First posted22 Dec 2020
Study start10 Feb 2021
Primary completion15 Apr 2021
Study completion27 Apr 2021

Why it stopped: Business reasons

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 Renal ImpairmentStudies 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: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04678505
Sponsor's protocol ID: 3402-004
Other IDs: MK-3402-004
Status last verified: Apr 2022
First submitted: 16 Dec 2020
Last updated: 4 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/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?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Trial to Evaluate the Pharmacokinetics of MK-3402 Following Administration of a Single IV Dose to Participants With Mild, Moderate, and Severe Renal Impairment and End-Stage Renal Disease
ClinicalTrials.gov ID: NCT04678505
Acronym / sponsor ID: 3402-004
Conditions: Renal Impairment
Keywords: MK-3402
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business reasons
Enrolment: 9 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 10 Feb 2021 (actual)
Primary completion: 15 Apr 2021 (actual)
Study completion: 27 Apr 2021 (actual)
First posted: 22 Dec 2020 (actual)
Results: Posted 4 Nov 2022

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
Panel A: Mild Renal Impairment	Experimental	Drug: MK-3402Participants with mild renal impairment will receive a single dose of 100 mg MK-3402 via intravenous (IV) infusion on Day 1.
Panel B: Moderate Renal Impairment	Experimental	Drug: MK-3402Participants with moderate renal impairment will receive a single dose of 100 mg MK-3402 via IV infusion on Day 1.
Panel C: Severe Renal Impairment	Experimental	Drug: MK-3402Participants with severe renal impairment will receive a single dose of 100 mg MK-3402 via IV infusion on Day 1.
Panel D: Healthy Participants	Experimental	Drug: MK-3402Healthy matched control participants will receive a single dose of 100 mg MK-3402 via IV infusion on Day 1.
Panel E: End-Stage Renal Disease (ESRD) Undergoing Hemodialysis	Experimental	Drug: MK-3402Participants with ESRD undergoing HD will receive a single dose of 100 mg MK-3402 via IV infusion after HD on Day 1 of Period 1 and before HD on Day 1 of Period 2. There will be at least a 6-day washout period before dosing in Period 2.

Who may qualify

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

Key inclusion criteria (13 listed)

Is in good health based on medical history, physical examination, vital signs (VS) measurements, and electrocardiogram (ECG)s performed before randomization.
Is in good health based on laboratory safety tests obtained at the screening visit and before administration of the initial dose of study drug.
Has a body mass index (BMI) ≥18 kg/m2 and ≤40 kg/m2. BMI = weight (kg)/height (m)2.
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
A female participant is eligible to participate if she is a woman of non-childbearing potential.

Key exclusion criteria (11 listed)

Panels A, B, C and E: Has a history of any clinically significant concomitant disease or condition (including treatment for such conditions) or diseases whose current condition is considered clinically unstable that, in the opinion of the investigator, could either interfere with the study drug, compromise interpretation of study data, or pose an unacceptable risk to the patient.
Panel D: Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.
Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder that would impact study conduct. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator.
Has a history of cancer (malignancy).
Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food.

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-3402MK-3402 administered as a single dose of 100 mg IV infusion on the following dosage days: Panels A to D: Day 1 Panel E: Day 1 in Periods 1 and 2	Drug	Panel A: Mild Renal Impairment, Panel B: Moderate Renal Impairment, Panel C: Severe Renal Impairment, Panel D: Healthy Participants, Panel E: End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

Primary outcome

Area Under the Curve From Dosing to Infinity (AUC0-inf) of MK-3402
Time frame: Pre-dose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
AUC0-inf is defined as area under the plasma concentration-time curve from dosing to infinity.
Plasma Concentration at the End of Infusion (Ceoi) of MK-3402
Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Ceoi is defined as the amount of study drug in plasma following IV infusion administration of study drug. Plasma samples were collected at pre-specified time points and Ceoi was assessed.
Time to Maximum Plasma Concentration (Tmax) of MK-3402
Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Tmax is defined as the time required for a study drug to reach maximum concentration in plasma. Plasma samples were collected at pre-specified time points and Tmax was assessed.
Apparent Plasma Half-life (t½) of MK-3402
Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak.
Apparent Plasma Clearance (CL) of MK-3402
Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
CL is defined as the time it takes for the study drug to be completely removed from the body's plasma.
Volume of Distribution (Vd) of MK-3402
Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1
Vd is defined as the distributed volume of study drug in plasma.

10 secondary outcomes

Number of Participants With Adverse Events (AE)
Time frame: Up to 15 days
Number of Participants Who Discontinued From Study Due to an AE
Time frame: Up to 15 days
Dialysis Clearance Based on Plasma (CLDplasma) of MK-3402
Time frame: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Concentration of Dialysate (CD) of MK-3402
Time frame: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Amount of Drug Recovered From the Dialysate From Plasma (AED) of MK-3402
Time frame: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Percentage of AED (% Dose) of MK-3402
Time frame: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion.
Hemodialysis Clearance Based on Plasma (CLD Dialysate) of MK-3402
Time frame: Panel E, Period 2: Pre-dose and 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after the start of infusion
Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-3402
Time frame: Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose
Fraction of Dose Recovered in Urine (Fe) of MK-3402
Time frame: Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose
Renal Clearance (CLr) of MK-3402
Time frame: Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose

Results and safety

Results posted to the registry on 4 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Panel A: Mild Renal Impairment	4	4
Panel B: Moderate Renal Impairment	5	5
Panel C: Severe Renal Impairment	0	0
Panel D: Healthy Participants	0	0
Panel E: End-Stage Renal Disease (ESRD) Undergoing Hemodialysis	0	0

Primary outcome: Area Under the Curve From Dosing to Infinity (AUC0-inf) of MK-3402

Time frame: Pre-dose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: hr*µmol/L

Measure	Panel A: Mild Renal Impairment n = 4	Panel B: Moderate Renal Impairment n = 5
Value	71.9 (18.2)	96.4 (17.5)

Population analysed: Participants who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model, are included. As the study was terminated early, no participants were enrolled in Panels C, D, or E.

Primary outcome: Plasma Concentration at the End of Infusion (Ceoi) of MK-3402

Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: µmol/L

Measure	Panel A: Mild Renal Impairment n = 4	Panel B: Moderate Renal Impairment n = 5
Value	16.8 (26.0)	14.3 (31.1)

Primary outcome: Time to Maximum Plasma Concentration (Tmax) of MK-3402

Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1. Median (Full Range). Unit: hours

Measure	Panel A: Mild Renal Impairment n = 4	Panel B: Moderate Renal Impairment n = 5
Value	0.59 (0.53 to 0.62)	0.57 (0.55 to 0.75)

Primary outcome: Apparent Plasma Half-life (t½) of MK-3402

Time frame: Predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1. Geometric mean (Geometric Coefficient of Variation). Unit: hours

Measure	Panel A: Mild Renal Impairment n = 4	Panel B: Moderate Renal Impairment n = 5
Value	5.06 (15.2)	8.12 (9.1)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 15 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panel A: Mild Renal Impairment	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Panel B: Moderate Renal Impairment	0 of 5 (0%)	2 of 5 (40%)	0 of 5

Limitations and caveats (from the sponsor): Due to early study termination, some of the planned endpoints were not able to be completed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-3402 in people with Renal Impairment, run by Merck Sharp & Dohme LLC at 2 sites in United States.

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 13 inclusion and 11 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: stopped early, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 4 Nov 2022). 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 Curve From Dosing to Infinity (AUC0-inf) of MK-3402 (time frame: Pre-dose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 1). 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?

On the ClinicalTrials.gov record for NCT04678505.

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 4 Nov 2022.