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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419910
• Other study ID #: IM011-045
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2018
• Est. completion date: May 4, 2018

Study information

• Verified date: March 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 4, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BMS-986165
Specified dose on specified days
• Cyclosporine
Specified dose on specified days

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration (Cmax)		24 hours
Primary	Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])		24 hours
Secondary	Adverse events (AEs)		Up to 20 days

External Links

•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry Form