Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01140061
Recruitment Status : Completed
First Posted : June 9, 2010
Results First Posted : December 12, 2014
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: MK-0873 Patch
Drug: MK-0873 Cream
Drug: Placebo Patch
Drug: Placebo Cream
Drug: Plain patch
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Panel A - MK-0873 5.1 mg Panel A - Placebo Panel B - MK-0873 25 mg Panel B - Placebo Panel C - MK-0873 100 mg Panel C - Placebo Panel D - MK-0873 200 mg Panel D - Placebo Panel E and Extension - MK-0873 200 mg Panel E and Extension - Placebo
Hide Arm/Group Description In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days. In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days. In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days. In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days. In Part II, healthy participants received skin application of placebo cream once daily for 10 days. In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days. In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days. In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
Period Title: Part I
Started 7 [1] 2 0 0 0 0 0 0 0 0
Completed 6 2 0 0 0 0 0 0 0 0
Not Completed 1 0 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0             0             0             0             0             0
[1]
Includes 1 replacement participant
Period Title: Part II
Started 0 0 6 2 6 2 6 2 0 0
Completed 0 0 6 2 6 2 6 2 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0
Period Title: Part III
Started 0 0 0 0 0 0 0 0 7 2 [1]
Completed 0 0 0 0 0 0 0 0 7 2
Not Completed 0 0 0 0 0 0 0 0 0 0
[1]
Includes 1 replacement participant
Period Title: Extension
Started 0 0 0 0 0 0 0 0 7 2
Completed 0 0 0 0 0 0 0 0 7 1
Not Completed 0 0 0 0 0 0 0 0 0 1
Reason Not Completed
Laboratory Adverse Event             0             0             0             0             0             0             0             0             0             1
Arm/Group Title Panel A - MK-0873 5.1 mg Panel A - Placebo Panel B - MK-0873 25 mg Panel B - Placebo Panel C - MK-0873 100 mg Panel C - Placebo Panel D - MK-0873 200 mg Panel D - Placebo Panel E and Extension - MK-0873 200 mg Panel E and Extension - Placebo Total
Hide Arm/Group Description In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days. In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days. In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days. In Part II, healthy participants received skin application of placebo cream once daily for 10 days. In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days In Part II, healthy participants received skin application of placebo cream twice daily for 10 days. In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days. In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days. Total of all reporting groups
Overall Number of Baseline Participants 7 2 6 2 6 2 6 2 7 2 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 7 participants 2 participants 6 participants 2 participants 6 participants 2 participants 6 participants 2 participants 7 participants 2 participants 42 participants
42.71
(23 to 53)
30.50
(18 to 43)
40.00
(26 to 60)
45.50
(35 to 56)
45.67
(28 to 62)
34.00
(29 to 39)
30.33
(21 to 38)
35.50
(34 to 37)
42.86
(23 to 54)
40.00
(29 to 51)
39.67
(18 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 2 participants 6 participants 2 participants 6 participants 2 participants 6 participants 2 participants 7 participants 2 participants 42 participants
Female
5
  71.4%
1
  50.0%
3
  50.0%
1
  50.0%
1
  16.7%
0
   0.0%
4
  66.7%
1
  50.0%
5
  71.4%
1
  50.0%
22
  52.4%
Male
2
  28.6%
1
  50.0%
3
  50.0%
1
  50.0%
5
  83.3%
2
 100.0%
2
  33.3%
1
  50.0%
2
  28.6%
1
  50.0%
20
  47.6%
1.Primary Outcome
Title Number of Participants With an Adverse Event of Erythema in Part I of the Study
Hide Description Following topical administration of MK-0873 or matching placebo patches once daily for 21 days, the number of participants with an adverse event of erythema was recorded. An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame Up to Day 22 in Part 1
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants who received at least one dose of study medication in Part I of the study.
Arm/Group Title Panel A - MK-0873 5.1 mg Panel A - Placebo
Hide Arm/Group Description:
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
Overall Number of Participants Analyzed 7 2
Measure Type: Number
Unit of Measure: Participants
0 0
2.Primary Outcome
Title Mean Maximum Plasma Concentration (Cmax) of MK-0873 Following Topical Administration for 10 Days
Hide Description Participant blood samples were collected on Day 11 to determine the Cmax of MK-0873 following topical administration in healthy participants and participants with psoriasis
Time Frame Day 11
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants who received MK-0873 and for whom blood samples were collected and evaluable to determine Cmax.
Arm/Group Title Panel A - MK-0873 5.1 mg Panel B - MK-0873 25 mg Panel C - MK-0873 100 mg Panel D - MK-0873 200 mg Panel E and Extension - MK-0873 200 mg
Hide Arm/Group Description:
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: nM
NA [1]   (NA) 9.10  (1.52) 5.22  (2.97) 12.0  (3.41) 9.76  (6.42)
[1]
The value was below the lower limit of quantification.
3.Primary Outcome
Title Number of Participants With an Adverse Event
Hide Description An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame Up to 14 days after last dose of study drug (up to Day 42)
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants who received at least one dose of study medication for whom safety data were available.
Arm/Group Title Panel A - MK-0873 5.1 mg Panel B - MK-0873 25 mg Panel C - MK-0873 100 mg Panel D - MK-0873 200 mg Panel E and Extension - MK-0873 200 mg Placebo - Pooled
Hide Arm/Group Description:
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
Overall Number of Participants Analyzed 7 6 6 6 7 10
Measure Type: Number
Unit of Measure: Participants
3 3 4 6 6 4
4.Primary Outcome
Title Number of Participants Who Discontinued Study Medication Due to an Adverse Event
Hide Description An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame Up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The population consisted of all enrolled participants who received at least one dose of study medication.
Arm/Group Title Panel A - MK-0873 5.1 mg Panel B - MK-0873 25 mg Panel C - MK-0873 100 mg Panel D - MK-0873 200 mg Panel E and Extension - MK-0873 200 mg Placebo - Pooled
Hide Arm/Group Description:
In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
Overall Number of Participants Analyzed 7 6 6 6 7 10
Measure Type: Number
Unit of Measure: Participants
1 0 0 0 0 0
Time Frame Part I: up to Day 36; Part II: up to Day 24; Part III: up to Day 42
Adverse Event Reporting Description The population consisted of all enrolled participants who received at least one dose of study medication and for whom safety data were available.
 
Arm/Group Title Panel A - MK-0873 5.1 mg Panel B - MK-0873 25 mg Panel C - MK-0873 100 mg Panel D - MK-0873 200 mg Panel E and Extension - MK-0873 200 mg Placebo - Pooled
Hide Arm/Group Description In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days. In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days. In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days. In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days. In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days. In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
All-Cause Mortality
Panel A - MK-0873 5.1 mg Panel B - MK-0873 25 mg Panel C - MK-0873 100 mg Panel D - MK-0873 200 mg Panel E and Extension - MK-0873 200 mg Placebo - Pooled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Panel A - MK-0873 5.1 mg Panel B - MK-0873 25 mg Panel C - MK-0873 100 mg Panel D - MK-0873 200 mg Panel E and Extension - MK-0873 200 mg Placebo - Pooled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/7 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Panel A - MK-0873 5.1 mg Panel B - MK-0873 25 mg Panel C - MK-0873 100 mg Panel D - MK-0873 200 mg Panel E and Extension - MK-0873 200 mg Placebo - Pooled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/7 (42.86%)   3/6 (50.00%)   4/6 (66.67%)   6/6 (100.00%)   6/7 (85.71%)   4/10 (40.00%) 
Gastrointestinal disorders             
Constipation  1  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%)  0/10 (0.00%) 
Diarrhoea  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Epigastric discomfort  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Vomiting  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
General disorders             
Injection-site reaction  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Infections and infestations             
Upper Respiratory Tract Infection  1  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/10 (0.00%) 
Nasopharyngitis  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Injury, poisoning and procedural complications             
Laceration  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Thermal burn  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back Pain  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/10 (0.00%) 
Arthralgia  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Muscle spasms  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Myalgia  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Nervous system disorders             
Burning Sensation  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/10 (10.00%) 
Headache  1  1/7 (14.29%)  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  2/7 (28.57%)  0/10 (0.00%) 
Somnolence  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/10 (0.00%) 
Dysgeusia  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Hyperaesthesia  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Paraesthesia  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Renal and urinary disorders             
Pyuria  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders             
Dermatitis Contact  1  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/10 (0.00%) 
Pruritus  1  0/7 (0.00%)  1/6 (16.67%)  3/6 (50.00%)  3/6 (50.00%)  2/7 (28.57%)  3/10 (30.00%) 
Rash  1  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/10 (0.00%) 
Hyperhidrosis  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/10 (0.00%) 
Vascular disorders             
Flushing  1  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01140061     History of Changes
Other Study ID Numbers: 0873-020
First Submitted: June 7, 2010
First Posted: June 9, 2010
Results First Submitted: October 29, 2014
Results First Posted: December 12, 2014
Last Update Posted: February 8, 2019