A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536961
• Other study ID #: IM011-136
• Status: Completed
• Phase: Phase 1
• Start date: September 10, 2020
• Est. completion date: December 25, 2020

Study information

• Verified date: October 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the drug levels of BMS-986165 in when taken by mouth as various solid tablet prototypes, by healthy participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 25, 2020
• Est. primary completion date: December 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Inclusion Criteria:

• No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations.

• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight =50 kg (110 lb). BMI = weight (kg)/(height [m])2 at screening.

• Willing and able to consume 4 units of alcohol (Part B only)

• A negative polymerase chain reaction (PCR) test for coronavirus disease 2019 (COVID-19) at screening and admission

• Males and females must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

• Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug

• Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.

• Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening.

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Reference Treatment- BMS-986165-01
Specified dose on specified days
• Prototype BMS-986165
Specified dose on specified days
• Famotidine
Specified dose on specified days

Other:
• Alcohol
Specified quantity on specified days

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences Miami	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of BMS-986165		Day 1 and Day 7
Primary	Time of maximum observed plasma concentration (Tmax) of BMS-986165		Day 1 and Day 7
Primary	Area under the plasma concentration-time curve from time zero to t (AUC (0-t)) of BMS-986165	Part A, B, C	Day 1 and Day 7
Secondary	Incidence of Nonserious Adverse Events (AEs)		Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B)
Secondary	Incidence of Serious Adverse Events (AEs)		Up to approximately 83 days (for Parts A & C), approximately 92 days (for Part B)
Secondary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Secondary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Secondary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF	QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave.	Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS	QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization	Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval	The QT interval is the time from the start of the Q wave to the end of the T wave.	Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Secondary	Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval	PR interval is the time from the onset of the P wave to the start of the QRS complex	Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form