Respiratory Syncytial Viruses
Conditions
Brief summary
The primary objective of this study is to determine if a single intravenous (IV) dose of clesrovimab when administered at 1 of 4 dose levels results in a reduction in viral load after intranasal inoculation (with RSV A Memphis 37b) compared to IV placebo. It is hypothesized that at least 1 of the 4 dose levels of clesrovimab given prior to inoculation will reduce the area under the viral load-time curve (VL-AUC) from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40) compared to placebo.
Interventions
BIOLOGICALClesrovimab
Single dose of clesrovimab administered via IV infusion.
OTHERPlacebo
Placebo (0.9% sodium chloride, USP sterile saline) administered via IV infusion.
BIOLOGICALRSV-A Memphis 37b
Approximately 4Log10 plaque-forming units (PFU)/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Is a male or female 18 to 55 years of age in good health with no history of major medical conditions that will interfere with participant safety, as defined by medical history, physical examination (including vital signs), electrocardiogram (ECG), and routine laboratory tests and determined by the Investigator at a screening evaluation. * Has a total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m\^2 and ≤ 30kg/m\^2. * If male, agrees to study contraceptive requirements at dosing and continuing until 90 days after dosing or 28 days after viral inoculation (whichever is later) and to not donate sperm until 90 days after dosing. * If female, has a negative pregnancy test at screening and prior to dosing and agrees to use one form of highly effective contraception if a woman of childbearing potential (WOCBP), or is not a WOCBP. * Has serology results within 90 days of dosing that suggest the participant is sensitive to RSV infection (i.e., that they are likely to become infected following inoculation).
Exclusion criteria
* Is a female who is breastfeeding or has been pregnant within 6 months prior to enrollment. * Has a history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immune suppression), metabolic, urological, renal, neurological, or psychiatric disease (including participants with a history of depression and/or anxiety with associated severe psychiatric comorbidities. * Has any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral inoculation (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month will be excluded). * Has any clinically significant history of epistaxis (large nosebleeds) within the last 3 months prior to IMP dosing and/or history of being hospitalized due to epistaxis on any previous occasion. * Has a history or currently active symptoms suggestive of upper or lower respiratory tract infection within 6 weeks prior to dosing. * Has any other major disease that, in the opinion of the Investigator, may interfere with a participant completing the study and necessary investigations. * Has a history of anaphylaxis-and/or a history of severe allergic reaction or significant intolerance to any food or drug, as assessed by the investigator. * Has confirmed positive test for drugs of abuse prior to randomization. * Has a history or presence of alcohol addiction, or excessive use of alcohol (weekly intake in excess of 28 units alcohol; 1 unit being a half glass of beer, a small glass of wine or a measure of spirits), or excessive consumption of xanthine containing substances (e.g. daily intake in excess of 5 cups of caffeinated drinks e.g. coffee, tea, cola). * Is positive for human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test. * Has evidence of receipt of vaccine within the 4 weeks prior to IMP dosing. * Has intention to receive any vaccine(s) before the last day of Follow-up. * Receipt of blood or blood products, or loss (including blood donations) of 470 mL or more of blood during the 3 months prior IMP dosing or planned during the 3 months after the final visit. * Has use within 7 days prior to IMP dosing of any medication or product (prescription or over-the-counter), for symptoms of hay fever, dermatitis, nasal congestion or respiratory tract infections including the use of regular nasal or dermal corticosteroids or antibiotics, apart from those allowed in the study. * Has received systemic (intravenous and/or oral) glucocorticoids or systemic antiviral drugs within 6 months prior to IMP dosing. * Has received chronic (defined as more than 14 continuous days) or current administration of a systemic immunosuppressant or other immune modifying drug, including any dose of oral corticosteroids, within 6 months prior to dose administration. The use of topical, inhaled, and nasal glucocorticoids will be permitted. * Has used or anticipated use during the conduct of the study of concomitant medications (prescription and/or non-prescription), including vitamins or herbal and dietary supplements within the specified windows (within 7 days prior to IMP dosing), unless in the opinion of the Principal Investigator, the medication will not interfere with the study procedures, outcomes, or compromise participant safety. * Has a history (participant recall) of receiving any human immunoglobulin preparation * Has received any investigational drug within 3 months prior to IMP dosing. * Has received ≥3 investigational drugs within the previous 12 months prior to IMP dosing. * Has prior participation in another Human Viral Challenge study with a respiratory virus of the same virus family in the preceding 3 months taken from the date of viral challenge in the previous study to the date of expected viral inoculation in this study. * Has prior participation in any RSV related (vaccine, monoclonal antibody or small molecule) interventional trial. * Has a forced expiratory volume in 1 second (FEV1) \< 80%. * Has presence of fever, defined as participant presenting with a temperature reading of ≥ 37.9°C on day of IMP dosing. * Has smoked ≥ 10 pack years at any time \[10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years\]). * Has venous access deemed inadequate for the phlebotomy and demands of the study. * Presents any concern by the investigator regarding safe participation in the study or for any other reason the investigator considers the participant inappropriate for participation in the study. * Has any contraindication for IV infusion. * Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Viral Load-time Curve (VL-AUC) | 10 days; from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40) | The VL-AUC will be determined by reverse transcription qualitative integrated cycler polymerase chain reaction (RT-qPCR) after viral inoculation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Symptomatic Respiratory Syncytial Virus (RSV) Infection | 10 days; from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40) | Symptomatic RSV infection is defined as presence of at least 2 quantifiable RT-qPCR at ≥2 consecutive days, plus symptoms of either any grade from 2 different symptoms from the Subject Symptom Card (SSC) or at least one Grade 2 symptom from ≥1 respiratory categories. |
| Number of Participants With an Adverse Event (AE) | Up to 187 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Number of Participants With a Serious Adverse Event (SAE) | Up to 187 days | An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. |
| Serum Concentration of MK-1654 | Predose and Days 1 (1, 2, and 4 hours postdose), 8, 15, 29, 40, and 57 | The post-dosing concentration of MK-1654 will be determined in serum. On Day 1, 3 samples will be taken at 1, 2, and 4 hours after administration. |
| Concentration of RSV Serum Neutralizing Antibody Titers | Days 1, 29, 40, and 57 | RSV serum neutralization titers were determined by enzyme-linked immunosorbent assay (ELISA). |
Countries
United Kingdom
Participant flow
Recruitment details
Healthy adult male and female participants were recruited at a single study site in the United Kingdom.
Participants by arm
| Arm | Count |
|---|---|
| MK-1654 100 mg Participants receive a single IV infusion of MK-1654 100 mg on Day 1. | 16 |
| MK-1654 200 mg Participants receive a single IV infusion of MK-1654 200 mg on Day 1. | 16 |
| MK-1654 300 mg Participants receive a single IV infusion of MK-1654 300 mg on Day 1. | 16 |
| MK-1654 900 mg Participants receive a single IV infusion of MK-1654 900 mg on Day 1. | 16 |
| Placebo Participants receive a single IV infusion of placebo on Day 1. | 16 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 | 1 | 0 | 0 |
| Overall Study | Various reasons | 2 | 0 | 0 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | MK-1654 100 mg | MK-1654 200 mg | MK-1654 300 mg | MK-1654 900 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 30.4 Years STANDARD_DEVIATION 6.9 | 27.1 Years STANDARD_DEVIATION 8.3 | 27.6 Years STANDARD_DEVIATION 8.7 | 26.4 Years STANDARD_DEVIATION 4.5 | 25.3 Years STANDARD_DEVIATION 4.1 | 27.4 Years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 16 Participants | 16 Participants | 16 Participants | 16 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 11 Participants | 14 Participants | 15 Participants | 14 Participants | 68 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 12 Participants | 5 Participants | 9 Participants | 35 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 4 Participants | 11 Participants | 7 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 11 / 16 | 12 / 16 | 12 / 16 | 8 / 16 | 11 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Area Under the Viral Load-time Curve (VL-AUC)
The VL-AUC will be determined by reverse transcription qualitative integrated cycler polymerase chain reaction (RT-qPCR) after viral inoculation.
Time frame: 10 days; from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40)
Population: All randomized participants who received a dose of study drug, a RSV inoculation, and had data available are included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| MK-1654 100 mg | Area Under the Viral Load-time Curve (VL-AUC) | 19.94 log10 copies-/ml*days |
| MK-1654 200 mg | Area Under the Viral Load-time Curve (VL-AUC) | 14.74 log10 copies-/ml*days |
| MK-1654 300 mg | Area Under the Viral Load-time Curve (VL-AUC) | 16.44 log10 copies-/ml*days |
| MK-1654 900 mg | Area Under the Viral Load-time Curve (VL-AUC) | 15.33 log10 copies-/ml*days |
| Placebo | Area Under the Viral Load-time Curve (VL-AUC) | 21.25 log10 copies-/ml*days |
Comparison: Treatment vs. Placebop-value: 0.80890% CI: [-10.25, 7.64]ANOVA
Comparison: Treatment vs. Placebop-value: 0.22990% CI: [-15.46, 2.43]ANOVA
Comparison: Treatment vs. Placebop-value: 0.36390% CI: [-13.58, 3.96]ANOVA
Comparison: Treatment vs. Placebop-value: 0.27390% CI: [-14.87, 3.02]ANOVA
Secondary
Concentration of RSV Serum Neutralizing Antibody Titers
RSV serum neutralization titers were determined by enzyme-linked immunosorbent assay (ELISA).
Time frame: Days 1, 29, 40, and 57
Population: All randomized participants who received a dose of study drug, a RSV inoculation, and had data available for the time point are included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MK-1654 100 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 40 | 4517.1 Titers |
| MK-1654 100 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 1, Predose | 669.1 Titers |
| MK-1654 100 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 57 | 4377.8 Titers |
| MK-1654 100 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 1, 2 hours postdose | 11137.6 Titers |
| MK-1654 100 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 29 | 4727.2 Titers |
| MK-1654 200 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 40 | 8357.6 Titers |
| MK-1654 200 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 29 | 8135.8 Titers |
| MK-1654 200 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 1, 2 hours postdose | 24836.1 Titers |
| MK-1654 200 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 57 | 5531.9 Titers |
| MK-1654 200 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 1, Predose | 699.3 Titers |
| MK-1654 300 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 29 | 13263.2 Titers |
| MK-1654 300 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 1, Predose | 954.0 Titers |
| MK-1654 300 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 1, 2 hours postdose | 41544.8 Titers |
| MK-1654 300 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 40 | 13510.9 Titers |
| MK-1654 300 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 57 | 11557.9 Titers |
| MK-1654 900 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 57 | 22209.6 Titers |
| MK-1654 900 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 1, Predose | 893.8 Titers |
| MK-1654 900 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 40 | 27935.5 Titers |
| MK-1654 900 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 29 | 31367.8 Titers |
| MK-1654 900 mg | Concentration of RSV Serum Neutralizing Antibody Titers | Day 1, 2 hours postdose | 100163.5 Titers |
| Placebo | Concentration of RSV Serum Neutralizing Antibody Titers | Day 29 | 1037.1 Titers |
| Placebo | Concentration of RSV Serum Neutralizing Antibody Titers | Day 40 | 1540.4 Titers |
| Placebo | Concentration of RSV Serum Neutralizing Antibody Titers | Day 1, Predose | 837.4 Titers |
| Placebo | Concentration of RSV Serum Neutralizing Antibody Titers | Day 57 | 1500.2 Titers |
| Placebo | Concentration of RSV Serum Neutralizing Antibody Titers | Day 1, 2 hours postdose | 1225.4 Titers |
Secondary
Number of Participants With an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 187 days
Population: All participants who received any study intervention are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1654 100 mg | Number of Participants With an Adverse Event (AE) | 11 Participants |
| MK-1654 200 mg | Number of Participants With an Adverse Event (AE) | 12 Participants |
| MK-1654 300 mg | Number of Participants With an Adverse Event (AE) | 12 Participants |
| MK-1654 900 mg | Number of Participants With an Adverse Event (AE) | 8 Participants |
| Placebo | Number of Participants With an Adverse Event (AE) | 11 Participants |
Secondary
Number of Participants With a Serious Adverse Event (SAE)
An SAE is any untoward medical occurrence in a clinical study participant that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event.
Time frame: Up to 187 days
Population: All participants who received any study intervention are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1654 100 mg | Number of Participants With a Serious Adverse Event (SAE) | 0 Participants |
| MK-1654 200 mg | Number of Participants With a Serious Adverse Event (SAE) | 0 Participants |
| MK-1654 300 mg | Number of Participants With a Serious Adverse Event (SAE) | 0 Participants |
| MK-1654 900 mg | Number of Participants With a Serious Adverse Event (SAE) | 0 Participants |
| Placebo | Number of Participants With a Serious Adverse Event (SAE) | 0 Participants |
Secondary
Percentage of Participants With Symptomatic Respiratory Syncytial Virus (RSV) Infection
Symptomatic RSV infection is defined as presence of at least 2 quantifiable RT-qPCR at ≥2 consecutive days, plus symptoms of either any grade from 2 different symptoms from the Subject Symptom Card (SSC) or at least one Grade 2 symptom from ≥1 respiratory categories.
Time frame: 10 days; from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40)
Population: All randomized participants who received a dose of study drug, a RSV inoculation, and had data available are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MK-1654 100 mg | Percentage of Participants With Symptomatic Respiratory Syncytial Virus (RSV) Infection | 53.85 Percentage of Participants |
| MK-1654 200 mg | Percentage of Participants With Symptomatic Respiratory Syncytial Virus (RSV) Infection | 30.77 Percentage of Participants |
| MK-1654 300 mg | Percentage of Participants With Symptomatic Respiratory Syncytial Virus (RSV) Infection | 35.71 Percentage of Participants |
| MK-1654 900 mg | Percentage of Participants With Symptomatic Respiratory Syncytial Virus (RSV) Infection | 30.77 Percentage of Participants |
| Placebo | Percentage of Participants With Symptomatic Respiratory Syncytial Virus (RSV) Infection | 53.33 Percentage of Participants |
95% CI: [-36.57, 37.78]
95% CI: [-56.7, 15.53]
95% CI: [-53.09, 20.01]
Comparison: Treatment vs. Placebo95% CI: [-56.7, 15.53]
Secondary
Serum Concentration of MK-1654
The post-dosing concentration of MK-1654 will be determined in serum. On Day 1, 3 samples will be taken at 1, 2, and 4 hours after administration.
Time frame: Predose and Days 1 (1, 2, and 4 hours postdose), 8, 15, 29, 40, and 57
Population: All randomized participants who received MK-1654 and had no major protocol deviations are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MK-1654 100 mg | Serum Concentration of MK-1654 | Day 1, 2 hours postdose | 34.3 µg/mL | Standard Deviation 6.42 |
| MK-1654 100 mg | Serum Concentration of MK-1654 | Day 15 | 14.5 µg/mL | Standard Deviation 2.49 |
| MK-1654 100 mg | Serum Concentration of MK-1654 | Day 8 | 16.0 µg/mL | Standard Deviation 2.54 |
| MK-1654 100 mg | Serum Concentration of MK-1654 | Predose | 0.0369 µg/mL | Standard Deviation 0.148 |
| MK-1654 100 mg | Serum Concentration of MK-1654 | Day 1, 4 hours postdose | 33.3 µg/mL | Standard Deviation 6.19 |
| MK-1654 100 mg | Serum Concentration of MK-1654 | Day 57 | 9.46 µg/mL | Standard Deviation 2.01 |
| MK-1654 100 mg | Serum Concentration of MK-1654 | Day 40 | 10.2 µg/mL | Standard Deviation 1.74 |
| MK-1654 100 mg | Serum Concentration of MK-1654 | Day 1, 1 hour postdose | 16.4 µg/mL | Standard Deviation 3.13 |
| MK-1654 100 mg | Serum Concentration of MK-1654 | Day 29 | 11.9 µg/mL | Standard Deviation 2.11 |
| MK-1654 200 mg | Serum Concentration of MK-1654 | Day 1, 1 hour postdose | 36.0 µg/mL | Standard Deviation 6.65 |
| MK-1654 200 mg | Serum Concentration of MK-1654 | Day 40 | 21.4 µg/mL | Standard Deviation 3.18 |
| MK-1654 200 mg | Serum Concentration of MK-1654 | Day 57 | 18.7 µg/mL | Standard Deviation 2.6 |
| MK-1654 200 mg | Serum Concentration of MK-1654 | Predose | 0.00 µg/mL | Standard Deviation 0 |
| MK-1654 200 mg | Serum Concentration of MK-1654 | Day 1, 2 hours postdose | 72.6 µg/mL | Standard Deviation 12.5 |
| MK-1654 200 mg | Serum Concentration of MK-1654 | Day 1, 4 hours postdose | 68.8 µg/mL | Standard Deviation 11.5 |
| MK-1654 200 mg | Serum Concentration of MK-1654 | Day 8 | 33.0 µg/mL | Standard Deviation 5.48 |
| MK-1654 200 mg | Serum Concentration of MK-1654 | Day 15 | 29.1 µg/mL | Standard Deviation 4.19 |
| MK-1654 200 mg | Serum Concentration of MK-1654 | Day 29 | 23.1 µg/mL | Standard Deviation 3.06 |
| MK-1654 300 mg | Serum Concentration of MK-1654 | Day 40 | 35.6 µg/mL | Standard Deviation 7.16 |
| MK-1654 300 mg | Serum Concentration of MK-1654 | Day 8 | 56.7 µg/mL | Standard Deviation 12.8 |
| MK-1654 300 mg | Serum Concentration of MK-1654 | Day 57 | 32.3 µg/mL | Standard Deviation 6.14 |
| MK-1654 300 mg | Serum Concentration of MK-1654 | Day 1, 1 hour postdose | 62.6 µg/mL | Standard Deviation 16.8 |
| MK-1654 300 mg | Serum Concentration of MK-1654 | Day 29 | 38.5 µg/mL | Standard Deviation 6.99 |
| MK-1654 300 mg | Serum Concentration of MK-1654 | Day 15 | 47.6 µg/mL | Standard Deviation 8.57 |
| MK-1654 300 mg | Serum Concentration of MK-1654 | Day 1, 4 hours postdose | 122 µg/mL | Standard Deviation 26.9 |
| MK-1654 300 mg | Serum Concentration of MK-1654 | Predose | 0.00 µg/mL | Standard Deviation 0 |
| MK-1654 300 mg | Serum Concentration of MK-1654 | Day 1, 2 hours postdose | 125 µg/mL | Standard Deviation 25.7 |
| MK-1654 900 mg | Serum Concentration of MK-1654 | Day 57 | 79.5 µg/mL | Standard Deviation 15.5 |
| MK-1654 900 mg | Serum Concentration of MK-1654 | Predose | 0.00 µg/mL | Standard Deviation 0 |
| MK-1654 900 mg | Serum Concentration of MK-1654 | Day 1, 1 hour postdose | 134 µg/mL | Standard Deviation 45.1 |
| MK-1654 900 mg | Serum Concentration of MK-1654 | Day 1, 2 hours postdose | 298 µg/mL | Standard Deviation 46.8 |
| MK-1654 900 mg | Serum Concentration of MK-1654 | Day 1, 4 hours postdose | 287 µg/mL | Standard Deviation 46 |
| MK-1654 900 mg | Serum Concentration of MK-1654 | Day 8 | 140 µg/mL | Standard Deviation 24.1 |
| MK-1654 900 mg | Serum Concentration of MK-1654 | Day 29 | 103 µg/mL | Standard Deviation 16 |
| MK-1654 900 mg | Serum Concentration of MK-1654 | Day 40 | 88.5 µg/mL | Standard Deviation 13.4 |
| MK-1654 900 mg | Serum Concentration of MK-1654 | Day 15 | 123 µg/mL | Standard Deviation 21.6 |