A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03142165
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.6
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Fibrosis	Drug: BMS-986263; Other: Placebo; Drug: Diphenhydramine; Drug: Famotidine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: A Randomized, Placebo-Controlled, Double-Blind, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
• Actual Study Start Date: May 11, 2017
• Actual Primary Completion Date: Nov 29, 2017
• Actual Study Completion Date: Nov 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986263	Drug: BMS-986263; 3 weekly doses of 90 mg infused intravenous administration; Drug: Diphenhydramine; 50 mg intravenous administration; Drug: Famotidine; 20 mg intravenous administration
Placebo Comparator: Placebo	Other: Placebo; Placebo; Drug: Diphenhydramine; 50 mg intravenous administration; Drug: Famotidine; 20 mg intravenous administration

Outcome Measures

Primary Outcome Measures

1. Adverse Events (AE) [28 days]

   measured by incidences

2. Serious Adverse Events (SAE) [30 days]

   measured by incidences

3. Infusion related reactions [28 days]

   measured by incidences

4. Abnormalities in clinical laboratory tests [28 days]

   measured by incidences

5. Abnormal vital sign measurements [28 days]

   measured by incidences

6. Abnormal electrocardiogram measurements [28 days]

   measured by incidences

7. Physical examination abnormalities [28 days]

   measured by incidences

Secondary Outcome Measures

1. Cmax [28 days]

   Maximum observed plasma concentration

2. Tmax [28 days]

   Time of maximum observed plasma concentration

3. AUC(0-T) [28 days]

   Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration

4. AUC(TAU) [28 days]

   Area under the concentration-time curve in one dosing interval (multiple dose only)

5. T-HALF [28 days]

   Terminal phase half-life

6. CLT [28 days]

   Total body clearance after IV dose

7. AI_AUC [28 days]

   Accumulation Index, the ratio of AUC(TAU) at steady-state to that after the first dose (Day 15 only)

8. T-HALFeff_AUC [28 days]

   Effective elimination half-life that explains the degree of accumulation observed for AUC(TAU) (Day 15 only)

9. Ctrough [28 days]

   Trough observed plasma concentration

10. Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients [28 days]

    Investigation of population specific differences in PK

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 participants as determined by no clinically significant deviation from normal in medical history, physical exam, ECGs, and clinical laboratory determinations

• Weight within the range of ≥60 and ≤90 kg

• Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug

• WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days), plus 5 half-lives of BMS-986263 (7.5 days) plus 30 days (duration of ovulatory cycle) for a total of 90 days post-treatment completion

• Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days) plus 5 half-lives of BMS-986263 (7.5 days) plus the duration of sperm turnover (90 days) for a total of 118.5 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements

Exclusion Criteria:

• History or evidence of active infection and/or febrile illness within 7 days of Study Day 1 (e.g., bronchopulmonary, urinary, gastrointestinal, etc.)

• History of serious bacterial, fungal, or viral infections that let to hospitalization and IV antibiotic treatment within 90 days prior to screening, or any recent serious infection requiring antibiotic treatment within 30 days of Study Day 1

• History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection, or skin infection (recurrent or chronic infection is defined as ≥2 episodes within a 6 month period)

• Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history)

• History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

• Presence of active tuberculosis (TB), latent TB, or inadequately treated latent or active TB

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wcct Global, Llc	Cypress	California	United States	90630

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: NCT03142165
• Other Study ID Numbers: IM025-001
• First Posted: May 5, 2017
• Last Update Posted: Jan 12, 2018
• Last Verified: Jan 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fibrosis; Diphenhydramine; Promethazine; Famotidine

Study Results

No Results Posted as of Jan 12, 2018