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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: BMS-986165; Drug: Cyclosporine

• Registration Number: NCT03419910
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Study Start: 2018-03-05
• Primary Completion: 2018-05-04
• Study Completion: 2018-05-04
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986165 and cyclosporine	Cyclosporine	BMS-986165 and cyclosporine administered orally
BMS-986165 and cyclosporine	BMS-986165	BMS-986165 and cyclosporine administered orally

Primary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax)	24 hours
Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])	24 hours

Secondary Outcome Measures

Name	Time	Method
Adverse events (AEs)	Up to 20 days

Trial Locations

Locations (1)

PRA Health Sciences; 🇺🇸 Salt Lake City, Utah, United States