NCT04678505

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

Terminated Phase 1 Results posted Last updated 4 November 2022

What this trial tests

Phase 1 trial testing MK-3402 in Renal Impairment in 9 participants. Terminated before completion.

Timeline

10 February 2021

Primary endpoint
15 April 2021

27 April 2021

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	10 February 2021
Primary completion	15 April 2021
Estimated completion	27 April 2021
Sites	2 locations across United States

Drugs / interventions tested

• MK-3402 — full drug profile →

Conditions studied

• Renal Impairment — all drugs for Renal Impairment →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 75, any sex, with Renal Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Panel A: Mild Renal Impairment	71.9	± 18.2
Panel B: Moderate Renal Impairment	96.4	± 17.5

Plasma Concentration at the End of Infusion (Ceoi) of MK-3402 Primary · 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.

Group	Value	95% CI
Panel A: Mild Renal Impairment	16.8	± 26.0
Panel B: Moderate Renal Impairment	14.3	± 31.1

Time to Maximum Plasma Concentration (Tmax) of MK-3402 Primary · 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.

Group	Value	95% CI
Panel A: Mild Renal Impairment	0.59	0.53 – 0.62
Panel B: Moderate Renal Impairment	0.57	0.55 – 0.75

Apparent Plasma Half-life (t½) of MK-3402 Primary · 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.

Group	Value	95% CI
Panel A: Mild Renal Impairment	5.06	± 15.2
Panel B: Moderate Renal Impairment	8.12	± 9.1

Apparent Plasma Clearance (CL) of MK-3402 Primary · 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.

Group	Value	95% CI
Panel A: Mild Renal Impairment	3.13	± 18.5
Panel B: Moderate Renal Impairment	2.28	± 16.1

Volume of Distribution (Vd) of MK-3402 Primary · 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.

Group	Value	95% CI
Panel A: Mild Renal Impairment	22.9	± 5.3
Panel B: Moderate Renal Impairment	26.6	± 20.4

Number of Participants With Adverse Events (AE) Secondary · Up to 15 days

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

Group	Value	95% CI
Panel A: Mild Renal Impairment	0
Panel B: Moderate Renal Impairment	2

Number of Participants Who Discontinued From Study Due to an AE Secondary · Up to 15 days

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

Group	Value	95% CI
Panel A: Mild Renal Impairment	0
Panel B: Moderate Renal Impairment	0

Amount Recovered in Urine From 0 to 24 Hours (Ae0-24) of MK-3402 Secondary · Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose

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.

Group	Value	95% CI
Panel A: Mild Renal Impairment	91.8	± 32.7
Panel B: Moderate Renal Impairment	61.5	± 42.4

Fraction of Dose Recovered in Urine (Fe) of MK-3402 Secondary · Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose

Fe is defined as the fraction of the dose of study drug in urine.

Group	Value	95% CI
Panel A: Mild Renal Impairment	86.8	± 35.1
Panel B: Moderate Renal Impairment	59.7	± 41.2

Renal Clearance (CLr) of MK-3402 Secondary · Pre-dose and 0-4, 4-8, 8-12, and 12-24 hours postdose

CLr is defined as the time it takes for the study drug to be completely removed by the kidneys.

Group	Value	95% CI
Panel A: Mild Renal Impairment	2.81	± 48.6
Panel B: Moderate Renal Impairment	1.52	± 36.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 15 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Panel A: Mild Renal Impairment

Serious: 0/4 (0%)

Deaths: 0/4

Panel B: Moderate Renal Impairment

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (4 terms — click to expand)

Reaction	System	Panel A: Mild Renal Impair…	Panel B: Moderate Renal Im…
Diarrhoea	Gastrointestinal disorders	—	—
Vulvovaginal candidiasis	Infections and infestations	—	—
Activated partial thromboplastin time prolonged	Investigations	—	—
Ecchymosis	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04678505 adverse events section.

Sponsor's own description

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 participants with impaired renal function.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.