A Study to Assess the Clinical Effects of Navarixin in Participants With Psoriasis (MK-7123-009)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Navarixin 10 mg; Placebo
Intervention description: Navarixin capsules orally, once daily for 28 days.; Matching placebo capsules to Navarixin orally, once daily for 28 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis
      Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the
      Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin,
      and 4) to determine the multiple-dose pharmacokinetics of Navarixin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) 19 to 34, BMI = weight (kg)/height (m^2).

          -  Must have a diagnosis of psoriasis vulgaris (PASI >8) present for at least 1 year.
             Participants with an on-therapy PASI <=8 at Screening may be considered for inclusion.
             Participants must be discussed with the Sponsor prior to enrollment and the subject
             must have indicated that they are not satisfied with current therapy. To be included,
             participants must have a PASI >8 following washout of their current psoriasis therapy.

          -  Target lesion selected must be located on the head, trunk, arms or legs and be at
             least 10 cm^2 in size. The lesion's total numerical ratings for erythema,
             infiltration, and desquamation must be at least 6 out of the possible 12. Severity
             score for desquamation must be at least 2.

          -  Vital sign measurements (taken after ~3 minutes in a supine position) must be within
             the following ranges: oral body temperature between 35.0°C to 37.5°C; systolic blood
             pressure, 90 to 160 mm Hg; diastolic blood pressure, 45 to 90 mm Hg; pulse rate, 40 to
             100 bpm.

          -  Have stable disease (ie, off treatment PASI during Screening period and Baseline PASI
             should not differ by more than 40%).

          -  Clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within
             normal limits or clinically acceptable to the investigator/sponsor. Participants must
             have a neutrophil count of at least 2 x 10^9/L to be included.

          -  Free of any clinically significant disease (other than psoriasis).

          -  Willing to give written informed consent and able to adhere to dose and visit
             schedules.

          -  For female participants: Negative serum pregnancy test (beta-hCG) and urine pregnancy
             test. Agree to use medically accepted methods of contraception during and for an
             appropriate pre-study period while receiving protocol specified medication, and for 1
             month after stopping medication. Female participants of non-childbearing potential
             must be surgically sterilized or be postmenopausal.

          -  Male subject must agree to use an adequate form of contraception for the duration of
             the study.

          -  At Screening, ECG conduction intervals must be within gender specific normal range
             (ie, QTc for males <430 msec and females <450 msec) or if not within the normal range,
             the values must be considered clinically insignificant by the investigator and
             sponsor.

        Exclusion Criteria:

          -  Female participants who are pregnant, intend to become pregnant (within 3 months of
             ending the study), or are breastfeeding.

          -  Participants who, in the opinion of the investigator, will not be able to participate
             optimally in the study.

          -  Any surgical or medical condition which might significantly alter the absorption,
             distribution, metabolism or excretion of any drug.

          -  History of any infectious disease within 4 weeks prior to drug administration and/or
             are positive for hepatitis B surface antigen, hepatitis C antibodies or human
             immunodeficiency virus (HIV).

          -  Immunocompromised participants.

          -  Positive screen for drugs with a high potential for abuse or have a history of drug or
             alcohol abuse in the past 2 years.

          -  History of mental instability or who have been treated for mood disorders.

          -  Donated blood in the past 60 days.

          -  Previous treatment with study medication.

          -  Currently participating in another clinical study or have participated in a clinical
             study within 30 days.

          -  Part of the study staff personnel or family members of the study staff personnel.

          -  Demonstrated clinically significant (requiring intervention) allergic reactions or who
             are known to be allergic to components of local anesthetics.