The primary objective of this study is to characterize the safety and tolerability of MK-6194 following multiple doses among participants with moderate to severe atopic dermatitis who are unresponsive to other therapies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Arkansas Research Trials-Clinical Trials ( Site 0002)
North Little Rock, Arkansas, United States
Number of Participants Who Experience One or More Adverse Events (AEs)
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented.
Time frame: Up to approximately 169 days
Number of Participants Who Discontinue Study Intervention Due to an 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study intervention due to an AE is presented.
Time frame: Up to approximately 85 days
Area Under the Curve (AUC) From Days 1-15 (AUC1-15) of MK-6194
Blood samples were collected at pre-specified time points to determine the AUC1-15 of MK-6194 in plasma.
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, and Day 15
AUC From Days 29-43 (AUC29-43) of MK-6194
Blood samples were collected at pre-specified time points to determine the AUC29-43 of MK-6194 in plasma.
Time frame: Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Peak Serum Concentration (Cmax) of MK-6194 (Day 1 to 29)
Blood samples were collected at pre-specified time points to determine the Cmax of MK-6194 in plasma.
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Miami Dermatology and Laser Research ( Site 0025)
Miami, Florida, United States
Global Health Research Center, Inc. ( Site 0005)
Miami Lakes, Florida, United States
Genesis Clinical Research, LLC ( Site 0004)
Tampa, Florida, United States
ForCare Clinical Research ( Site 0003)
Tampa, Florida, United States
Advanced Medical Research, PC. ( Site 0027)
Sandy Springs, Georgia, United States
AXIS Clinicals ( Site 0029)
Dilworth, Minnesota, United States
Remington Davis Clinical Research ( Site 0021)
Columbus, Ohio, United States
Paddington Testing Company ( Site 0010)
Philadelphia, Pennsylvania, United States
North Texas Center for Clinical Research ( Site 0028)
Frisco, Texas, United States
...and 9 more locations
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)
Minimum Serum Concentration (Ctrough) of MK-6194 (Day 1 to 29)
Blood samples were collected at pre-specified time points to determine the Ctrough of MK-6194 in plasma.
Time frame: Predose on Days 15 and 29
Time to Peak Serum Concentration (Tmax) of MK-6194 (Day 1 to 29)
Blood samples were collected at pre-specified time points to determine the Tmax of MK-6194 in plasma.
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, and Day 29 (Predose and 12 hours postdose)
Geometric Mean Accumulation Ratio of AUC of MK-6194
Blood samples were collected at pre-specified time points to determine the geometric mean accumulation ratio of AUC of MK-6194. The accumulation ratio is defined as Day 29-43/ Day 1-15.
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Geometric Mean Accumulation Ratio of Cmax of MK-6194
Blood samples were collected at pre-specified time points to determine the geometric mean accumulation ratio of Cmax of MK-6194. The accumulation ratio is defined as Day 29-43/ Day 1-15.
Time frame: Day 1 (Predose and 12 hours postdose), Day 8, Day 15, Day 29 (Predose and 12 hours postdose), Day 36, and Day 43
Fold Change From Baseline in Peak Regulatory T Cells (Tregs)
Blood samples were collected to determine the fold change from baseline (FCB) in peak Tregs. The peak Treg FCB was evaluated after the last dose of MK-6194 on Day 85 using natural-log transformed values with a linear model containing fixed effects.
Time frame: Baseline and Day 85