Clinical trial NCT00684593: A Study to Assess the Clinical Effects of Navarixin in Participants With Psoriasis (MK-7123-009)
Official title: A Study to Assess the Clinical Effects of SCH 527123 in Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29
timeFrame: Baseline and Day 29
Secondary outcomes:
measure: Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
timeFrame: Day 29
measure: Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28
timeFrame: Day 28
measure: Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28
timeFrame: Day 28
measure: Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28
timeFrame: Day 28
measure: Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28
timeFrame: Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: