Overview

A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function

Status:
Completed
Trial end date:
2018-10-22
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bristol-Myers Squibb
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Body weight ≥ 45 kg and ≤ 120 kg

- BMI ≥ 18 kg/m^2 and ≤ 35 kg/m^2

- Heart rate ≥ 50 bpm and < 95 bpm

- Stable renal impairment, defined as no clinically significant change in disease
status, as documented by the subject's most recent eGFR assessment

- No changes in medication within 30 days prior to study drug administration

Exclusion Criteria:

- Clinically relevant abnormal medical history, abnormal findings on physical
examination, vital signs, ECG, or laboratory tests

- History of chronic headaches, defined as occurring 15 days or more a month, over the
previous 3 months

- History of headaches related to caffeine withdrawal

- History of migraine or cluster headaches

- Patients requiring dialysis will not be enrolled in this study

Other protocol defined inclusion/exclusion criteria could apply