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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 1

Conditions

Psoriasis

Treatments

Drug: Cyclosporine
Drug: BMS-986165

Study type

Interventional

Funder types

Industry

Identifiers

NCT03419910
IM011-045

Details and patient eligibility

About

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

Enrollment

54 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

54 participants in 1 patient group

BMS-986165 and cyclosporine
Experimental group
Description:
BMS-986165 and cyclosporine administered orally
Treatment:
Drug: Cyclosporine
Drug: BMS-986165

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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