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| Sponsor: | Sirtris, a GSK Company |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01154101 |
Purpose
This double-blind, placebo-controlled study will be conducted at 5 study centers in the United States. Approximately 30 subjects with moderate to severe plaque-type psoriasis will take part. The study will consist of a screening period of up to 21 days, a 12-week treatment period with 7 on-treatment clinic visits (approximately one every 2 weeks) and a post-dosing follow-up clinic visit approximately 30 days after the last dose of study drug is taken.
Subjects will be randomized to receive either 250mg, 500mg or 1000mg of study drug or placebo. Study drug will be taken by mouth on a full stomach, every day for 84 days.
Vital signs, clinical laboratory results (hematology, chemistry, and urinalysis), ECGs and physical examinations will be assessed at periodic intervals from Day 1 through Day 84.
A skin biopsy will be taken at the beginning and the end of the dosing period to evaluate any effects of the study drug on psoriasis. Investigators will perform other psoriasis evaluations (including the Psoriasis Area and Severity Index [PASI] and the Physician's Global Assessment [PGA] at 5 different times throughout the study to quantify the effects of SRT2104 on psoriasis activity.
Subjects will complete questionnaires throughout the study, to document their sense of well-being and mood at 4 different times during the study.
Five blood samples will be obtained at different timepoints during the study, to measure the amount of SRT2104 in the body.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: Placebo Drug: SRT2104 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study of the Clinical Activity, Safety, and Tolerability of SRT2104 in Subjects With Moderate to Severe Plaque-Type Psoriasis |
| Enrollment: | 40 |
| Study Start Date: | June 2010 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cohort 2 - 500mg SRT2104/placebo dose group
10 subjects will be randomized 4:1 (SRT2104: placebo) in each of 3 treatment arms (250mg, 500mg, or 1000mg). Cohort 2 will commence after Cohort 1 has completed 28 consecutive days of dosing, followed by the completion of a safety review by an Independent Safety Review Committee. Cohort 2 will be administered at approximately the same time every day, approximately 15 minutes following the consumption of food. Subjects must wait at least 1 hour after dosing before consuming additional calories. Dietary recommendations for the meal that precedes dosing will be provided to the study subjects by the clinical site staff. |
Drug: Placebo
For the placebo product, the SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product.
Drug: SRT2104
SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 250 mg of micronized SRT2104 powder with no additional additives into a size 00 opaque, hard gelatin capsule, packaged in dosing bottles containing a single daily dose.
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Active Comparator: Cohort 3 - 1000mg SRT2104/placebo dose group
10 subjects will be randomized 4:1 (SRT2104: placebo) in each of 3 treatment arms (250mg, 500mg, or 1000mg). Cohort 3 will commence after Cohort 2 has completed 28 consecutive days of dosing, followed by the completion of a safety review by an Independent Safety Review Committee. Cohort 3 will be administered four SRT2104 capsules at approximately the same time every day, approximately 15 minutes following the consumption of food. Subjects must wait at least 1 hour after dosing before consuming additional calories. Dietary recommendations for the meal that precedes dosing will be provided to the study subjects by the clinical site staff. |
Drug: Placebo
For the placebo product, the SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product.
Drug: SRT2104
SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 250 mg of micronized SRT2104 powder with no additional additives into a size 00 opaque, hard gelatin capsule, packaged in dosing bottles containing a single daily dose.
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Active Comparator: Cohort 1 - 250mg SRT2104/placebo dose group
10 subjects will be randomized 4:1 (SRT2104: placebo) in each of 3 treatment arms (250mg, 500mg, or 1000mg). Cohort 1 will be administered at approximately the same time every day, approximately 15 minutes following the consumption of food. Subjects must wait at least 1 hour after dosing before consuming additional calories. Dietary recommendations for the meal that precedes dosing will be provided to the study subjects by the clinical site staff. Dosing for Cohort 2 will not commence until Cohort 1 has completed 28 consecutive days of dosing, followed by the completion of a safety review by an Independent Safety Review Committee. |
Drug: Placebo
For the placebo product, the SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product.
Drug: SRT2104
SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 250 mg of micronized SRT2104 powder with no additional additives into a size 00 opaque, hard gelatin capsule, packaged in dosing bottles containing a single daily dose.
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Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Missouri | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63117 | |
| United States, New York | |
| GSK Investigational Site | |
| New York, New York, United States, 10065 | |
| GSK Investigational Site | |
| New York, New York, United States, 10016 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97223 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19103 | |
| United States, Rhode Island | |
| GSK Investigational Site | |
| Johnston, Rhode Island, United States, 02919 | |
| United States, Texas | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| United States, Washington | |
| GSK Investigational Site | |
| Seattle, Washington, United States, 98101 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01154101 History of Changes |
| Other Study ID Numbers: | 114296 |
| Study First Received: | April 22, 2010 |
| Last Updated: | February 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |