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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03419910
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arm: 1
• Actual Duration (Months): 2
• Patients Per Site Per Month: 27.4

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: N/A
• 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: Mar 5, 2018
• Actual Primary Completion Date: May 4, 2018
• Actual Study Completion Date: May 4, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Maximum concentration (Cmax) [24 hours]

2. Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24]) [24 hours]

Secondary Outcome Measures

1. Adverse events (AEs) [Up to 20 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Patient Recruiting

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03419910
• Other Study ID Numbers: IM011-045
• First Posted: Feb 5, 2018
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Psoriasis; Cyclosporine; BMS-986165; Cyclosporins

Study Results

No Results Posted as of Mar 18, 2020