A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis

• Status: Terminated
• Trial end date: 2018-06-26
• Target enrollment: 0
• Participant gender: All

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 itchy, dry skin with a scaly rash).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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:

1. Affected body surface area (BSA) of ≥10%

2. Psoriasis Area and Severity Index (PASI) ≥12

3. 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