Status:
TERMINATED
A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Psoriasis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to investigate experimental medication BMS-986251 taken by mouth in healthy patients and patients with average to very serious Psoriasis (a condition characterized by itch...
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Inclusion Criteria (Healthy Patients):
- Males and females, ages 18 to 55 years, inclusive, at screening
- Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, vital signs, and clinical laboratory results
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening
- Body weight between 55 kg and 105 kg, inclusive, at screening
- Women must not be breastfeeding
- Exclusion Criteria (Healthy Patients):
- Previous participation in the current study
- Participation in a drug study or exposure to any investigational drug or placebo within 2 months prior to (the first) drug administration in the current study
- Employees of PRA or the Sponsor and their relatives
- Any significant acute or chronic medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect pharmacokinetics; history of cholecystectomy is not allowed
- Inclusion Criteria (Psoriasis Patients):
- Males and females, ages 18 to 70 years, inclusive, at screening
- BMI of 18.0 to 35.0 kg/m2, inclusive, at screening
- Body weight between 55 kg and 120 kg, inclusive, at screening
- Diagnosed with stable chronic plaque psoriasis, for at least 6 months prior to screening and be candidates for either photo-therapy or systemic treatment
- Moderate-to-severe intensity of psoriasis as defined by:
- Affected body surface area (BSA) of ≥10%
- Psoriasis Area and Severity Index (PASI) ≥12
- Physician Global Assessment (PGA; 6-point scale) ≥3
- Exclusion Criteria (Psoriasis Patients):
- Previous participation in the current study
- Participation in a drug study or exposure to any investigational drug or placebo within 2 months prior to (the first) drug administration in the current study
- Employees of PRA or the Sponsor and their relatives
- Any significant acute or chronic medical condition that presents a potential risk to the subject and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect pharmacokinetics; history of cholecystectomy is not allowed
- Other protocol defined inclusion/exclusion criteria could apply
Exclusion
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2018
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03329885
Start Date
November 2 2017
End Date
June 26 2018
Last Update
October 21 2019
Active Locations (1)
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1
Local Institution
Groningen, Netherlands, 9728 NZ