Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890809
Recruitment Status : Active, not recruiting
First Posted : March 26, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.

Condition or disease Intervention/treatment Phase
Liver Dysfunction Healthy Volunteers Drug: BMS-986165 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS-986165 in Participants With Normal Hepatic Function and Participants With Mild, Moderate and Severe Hepatic Impairment
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : August 14, 2019
Estimated Study Completion Date : August 15, 2019

Arm Intervention/treatment
Experimental: Normal liver function
Single dose
Drug: BMS-986165
Oral administration

Experimental: Mild liver impairment
Single dose
Drug: BMS-986165
Oral administration

Experimental: Moderate liver impairment
Single dose
Drug: BMS-986165
Oral administration

Experimental: Severe liver impairment
Single dose
Drug: BMS-986165
Oral administration




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 9 days ]
  2. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 9 days ]
  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Approximately 9 days ]

Secondary Outcome Measures :
  1. Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation [ Time Frame: Approximately 44 days ]
  2. Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations [ Time Frame: Approximately 44 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
  • Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.73 m2 for participants

Exclusion Criteria:

  • Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant
  • History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening
  • Have a history of cancer (malignancy) with the following exceptions: (1) participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) participants with other malignancies who have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890809


Locations
Layout table for location information
United States, Texas
Local Institution
San Antonio, Texas, United States, 78215
Czechia
Pharmaceutical Research Associates CZ, s.r.o
Praha 7, Czechia, 170 00
Slovakia
Local Institution
Bratislava, Slovakia, 831 01
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03890809     History of Changes
Other Study ID Numbers: IM011-062
2018-002534-20 ( EudraCT Number )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Digestive System Diseases