A Phase 1 interventional study of MK-3866 in Hepatic Insufficiency and Antibacterial Agents, sponsored by Merck Sharp & Dohme LLC. Terminated at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-13.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment
Among 10 studies in Hepatic Insufficiency by Merck & Co., Inc — 1 open to participants now, 1 under way, none of them phase 3. Hepatic Insufficiency · Merck & Co., Inc.
Among the 10 studies in Hepatic Insufficiency by Merck & Co., Inc, this one is the 9th largest by enrollment, is the only one that started in 2017, is one of 10 in phase 1, and was the 7th registered.
113 studies on the registry are indexed under Hepatic Insufficiency; 15 are open to participants now.
Browse Hepatic Insufficiency studies →1 of the 10 studies in Hepatic Insufficiency by Merck & Co., Inc is open now. Recruiting first, the newest first:
Merck Sharp & Dohme LLC
Ages 18–75 · Healthy volunteers
Of the 9 Hepatic Insufficiency studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 9 is below the median of 29 across 100 interventional studies indexed under Hepatic Insufficiency.
Median enrollment 20 across the 10 interventional studies. Of the 9 that completed or were terminated, 5 (56%) have results posted.
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Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 502 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
1 of the studies in Hepatic Insufficiency by Merck & Co., Inc that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05093972Merck Sharp & Dohme LLCUlonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014) | 2027-06-29 |
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Among the 10 studies in Hepatic Insufficiency by Merck & Co., Inc, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is an open-label, single-dose, Phase 1 study to evaluate the pharmacokinetics (PK) of intravenous (IV) MK-3866 in participants with moderate and severe hepatic impairment (HI) compared to that of matched healthy participants. The primary purpose of this study is to understand the effect of HI on the plasma PK of MK-3866 in order to guide dosing recommendations for participants with HI. This study will also evaluate the safety and tolerability of MK-3866 in participants with moderate and severe HI.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with moderate HI (estimated glomerular filtration rate \[eGFR\] of ≤60mL/min/1.73m\^2) receive a single IV dose of MK-3866 (150 mg) on Day 1.
Drug: MK-3866
Participants with severe HI (eGFR of ≤50 mL/min/1.73m\^2) receive a single IV dose of MK-3866 (150 mg) on Day 1.
Drug: MK-3866
Healthy participants receive a single IV dose of MK-3866 (150 mg) on Day 1.
Drug: MK-3866
Single IV infusion of MK-3866 150 mg administered over 30 minutes at Hour 0 on Day 1 of treatment period.
Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞)
AUC0-∞ is determined for the period up to 72 hours post-single dose. AUC0-∞ is an estimate of total plasma exposure from dosing to (extrapolated) infinity.
Time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last)
AUC0-last is determined for the period up to 72 hours post-single dose. AUC0-last is an estimate of total plasma exposure from dosing to the time of last measurable sample.
Time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr)
AUC0-24 is determined for the period up to 24 hours post-single dose. AUC0-24 is an estimate of total daily plasma exposure from dosing to 24 hours postdose.
Time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours postdose
Concentration at the End of Infusion (Ceoi) of MK-3866
The plasma sample collected at end-of-infusion (0.5 hours postdose) was used to determine Ceoi.
Time frame: 0.5 (end of infusion) hours postdose
Time to Maximum Concentration (Tmax) of MK-3866
Tmax is the time at which the maximum plasma drug concentration is detected.
Time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
Apparent Terminal Half-life (t1/2) of MK-3866
Apparent t1/2 is the elimination half-life of MK-3866 from plasma.
Time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
Clearance (CL) of MK-3866
CL is the volume of plasma from which the study drug is completely removed per unit time.
Time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
Volume of Distribution (Vz) of MK-3866
Vz is the apparent volume of distribution during the terminal phase.
Time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
Fraction of Dose of MK-3866 Excreted Unchanged in Urine (Fe)
Fe is the amount of drug excreted unchanged in urine. Urine samples were collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.
Time frame: Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose
Renal Clearance (CLr) of MK-3866
CLr is the volume of plasma from which the study drug is completely removed per unit time by the kidney (i.e., excreted into the urine). Urine samples are collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.
Time frame: Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose
Number of Participants With at Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 14 days
Number of Participants Who Discontinued the Study Due to an AE
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 14 days
The study terminated prior to enrollment of any healthy control participants.
| Milestone | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Started | 5 | 4 |
| Completed | 5 | 4 |
| Not completed | 0 | 0 |
AUC0-∞ is determined for the period up to 72 hours post-single dose. AUC0-∞ is an estimate of total plasma exposure from dosing to (extrapolated) infinity.
| hour*µM | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞) | 71.4 ± 7.3 | 58.6 ± 41.4 |
AUC0-last is determined for the period up to 72 hours post-single dose. AUC0-last is an estimate of total plasma exposure from dosing to the time of last measurable sample.
| hour*µM | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last) | 70.7 ± 7.4 | 57.9 ± 42.2 |
AUC0-24 is determined for the period up to 24 hours post-single dose. AUC0-24 is an estimate of total daily plasma exposure from dosing to 24 hours postdose.
| hour*µM | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr) | 67.6 ± 7.5 | 54.6 ± 34.5 |
The plasma sample collected at end-of-infusion (0.5 hours postdose) was used to determine Ceoi.
| µM | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Concentration at the End of Infusion (Ceoi) of MK-3866 | 19.2 ± 22.0 | 11.0 ± 30.4 |
Tmax is the time at which the maximum plasma drug concentration is detected.
| hours | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Time to Maximum Concentration (Tmax) of MK-3866 | 0.47 (0.47 to 0.53) | 0.50 (0.47 to 1.00) |
Apparent t1/2 is the elimination half-life of MK-3866 from plasma.
| hours | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Apparent Terminal Half-life (t1/2) of MK-3866 | 6.54 ± 13.3 | 6.02 ± 4.16 |
CL is the volume of plasma from which the study drug is completely removed per unit time.
| Liters/hour | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Clearance (CL) of MK-3866 | 4.16 ± 7.3 | 5.07 ± 41.3 |
Vz is the apparent volume of distribution during the terminal phase.
| Liters | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Volume of Distribution (Vz) of MK-3866 | 39.3 ± 15.8 | 44.0 ± 27.4 |
Fe is the amount of drug excreted unchanged in urine. Urine samples were collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.
No measurements were reported for this outcome.
CLr is the volume of plasma from which the study drug is completely removed per unit time by the kidney (i.e., excreted into the urine). Urine samples are collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.
No measurements were reported for this outcome.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
| Participants | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Number of Participants With at Least One Adverse Event (AE) | 2 | 1 |
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
| Participants | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Number of Participants Who Discontinued the Study Due to an AE | 0 | 0 |
Collected over Up to 14 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moderate Hepatic Impairment (Panel A) | 0/5 (0%) | 0/5 (0%) | 2/5 (40%) |
| Severe Hepatic Impairment (Panel B) | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Event | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) |
|---|---|---|
| Skin abrasionInjury, poisoning and procedural complications | 0/5 | 1/4 |
| Abdominal painGastrointestinal disorders | 1/5 | 0/4 |
| DiarrhoeaGastrointestinal disorders | 1/5 | 0/4 |
| DysgeusiaNervous system disorders | 1/5 | 0/4 |
| Age, Continuous(Years) | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) | Total |
|---|---|---|---|
| Mean | 60.0 ± 5.96 | 56.0 ± 8.98 | 58.2 ± 7.24 |
| Sex: Female, Male(Participants) | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 4 | 3 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 3 | 2 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Moderate Hepatic Impairment (Panel A) | Severe Hepatic Impairment (Panel B) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 4 | 3 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Dec 2017 to primary completion in Mar 2018, 2 months.
Results were first posted in Nov 2019, 1 year 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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