A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02790125
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 5
• Actual Duration (Months): 15.3
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

The primary purpose of this study is to determine if single doses of BMS-986166 are safe and well tolerated in healthy male subjects and female subjects of non-childbearing potential.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: BMS-986166; Drug: Placebo matching BMS-986166	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Screening
• Official Title: A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
• Actual Study Start Date: Jul 28, 2016
• Actual Primary Completion Date: Nov 7, 2017
• Actual Study Completion Date: Nov 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Panel 1 BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified	Drug: BMS-986166; Drug: Placebo matching BMS-986166
Experimental: Dose Panel 2 BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified	Drug: BMS-986166; Drug: Placebo matching BMS-986166
Experimental: Dose Panel 3 BMS-986166 or Placebo matching BMS-986166 Single oral dose of solution as specified	Drug: BMS-986166; Drug: Placebo matching BMS-986166
Experimental: Dose Panel 4 BMS-986166 or Placebo matching BMS-986166 Multiple ascending solid dose formulation as specified	Drug: BMS-986166; Drug: Placebo matching BMS-986166
Experimental: Dose Panel 5a/b/c BMS-986166 Single oral solid dose formulation under fasting/fed/fasting with famotidine conditions	Drug: BMS-986166

Outcome Measures

Primary Outcome Measures

1. Incidence of All Adverse Events (AEs) [Baseline Day -1 to Day 65]

2. Incidence of Serious Adverse Events (SAEs) [Baseline Day -1 to Day 65]

3. Severity of all All Adverse Events (AEs) [Baseline Day -1 to Day 65]

4. Change from baseline in electrocardiogram(ECG) results [Baseline Day -1 to Day 35]

5. Change from baseline in body temperature [Baseline Day -1 to Day 35]

6. Change from baseline in respiratory rate [Baseline Day -1 to Day 35]

7. Change from baseline in seated blood pressure [Baseline Day -1 to Day 35]

8. Change from baseline in heart rate [Baseline Day -1 to Day 35]

9. Change from baseline in clinical laboratory test results [Baseline Day -1 to Day 35]

   Clinical laboratory testing to include Chemistry analytes and Hematology analytes.

10. Change from baseline in continuous cardiac monitoring data [Baseline Day -1 to Day 35]

11. Change from baseline in physical examination findings [Baseline Day -1 to Day 35]

Secondary Outcome Measures

1. Mean difference in nadir heart rate (HR) and its time-matched HR on Day -1 [Day -1 to Day 4]

2. Largest decrease in HR from time-matched Day -1 baseline [Day -1 to Day 4]

3. Time to nadir HR from time 0 hour (predose) [Day -1 to Day 4]

4. Percent reduction in HR at nadir from time-matched Day -1 HR value [Day -1 to Day 4]

5. Mean change from baseline in HR values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 HR value [Day -1 to Day 7]

6. Mean difference in absolute lymphocyte count (ALC) values and its time-matched ALC on Day -1 in BMS-986166- treated versus placebo-treated subjects [Day -1 to Day 4]

7. Largest decrease in ALC from time-matched Day -1 baseline [Day -1 to Day 4]

8. Time to nadir ALC from time 0 hour (predose) [Day -1 to Day 4]

9. Percent reduction in ALC at nadir from time-matched Day -1 value [Day -1 to Day 4]

10. Mean change from baseline in ALC values by timepoint for BMS-986166-treated versus placebo-treated subjects where the baseline is defined as time-matched Day -1 ALC value [Day -1 to Day 7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Inclusion Criteria:

• Healthy female subjects of non-childbearing potential or male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations

• Ages 18 to 55 years

• Female subjects must provide documentation of an acceptable method of surgical sterilization or meet the protocol criteria for menopause

Exclusion Criteria:

• Any acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor

• Any acute or chronic bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C, as defined in the protocol

• History of heart disease, neurological disease, eye disorders or gastrointestinal disorders or surgery (including cholecystectomy)

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs or clinical laboratory tests

• Smoking or nicotine use, drug or alcohol abuse within 6 months of starting the study

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Development, LLC	Austin	Texas	United States	78744

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: NCT02790125
• Other Study ID Numbers: IM018-001
• First Posted: Jun 3, 2016
• Last Update Posted: Nov 24, 2017
• Last Verified: Nov 1, 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 24, 2017