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An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants

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ClinicalTrials.gov Identifier: NCT03419910
Recruitment Status : Completed
First Posted : February 2, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: BMS-986165 Drug: Cyclosporine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : May 4, 2018
Actual Study Completion Date : May 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BMS-986165 and cyclosporine
BMS-986165 and cyclosporine administered orally
Drug: BMS-986165
Specified dose on specified days

Drug: Cyclosporine
Specified dose on specified days




Primary Outcome Measures :
  1. Maximum concentration (Cmax) [ Time Frame: 24 hours ]
  2. Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24]) [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: Up to 20 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body mass index 18.0 to 32.0 kg/m2
  • Weight ≥ 50 kg

Exclusion Criteria:

  • Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease
  • History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
  • Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
  • History of administration of live vaccines within 60 days before screening
  • Any history or risk for tuberculosis (TB)

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419910


Locations
United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03419910     History of Changes
Other Study ID Numbers: IM011-045
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors