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Completed

NCT Number: NCT03142165

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wcct Global, Llc

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986263

Drug

3 weekly doses of 90 mg infused intravenous administration

Placebo

Other

Placebo

diphenhydramine

Drug

50 mg intravenous administration

Famotidine

Drug

20 mg intravenous administration

Primary outcomes

  1. Adverse Events (AE)

    Time frame: 28 days

    measured by incidences

  2. Serious Adverse Events (SAE)

    Time frame: 30 days

    measured by incidences

  3. Infusion related reactions

    Time frame: 28 days

    measured by incidences

  4. Abnormalities in clinical laboratory tests

    Time frame: 28 days

    measured by incidences

  5. Abnormal vital sign measurements

    Time frame: 28 days

    measured by incidences

  6. Abnormal electrocardiogram measurements

    Time frame: 28 days

    measured by incidences

  7. Physical examination abnormalities

    Time frame: 28 days

    measured by incidences

Secondary outcomes

  1. Cmax

    Time frame: 28 days

    Maximum observed plasma concentration

  2. Tmax

    Time frame: 28 days

    Time of maximum observed plasma concentration

  3. AUC(0-T)

    Time frame: 28 days

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

  4. AUC(TAU)

    Time frame: 28 days

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

  5. T-HALF

    Time frame: 28 days

    Terminal phase half-life

  6. CLT

    Time frame: 28 days

    Total body clearance after IV dose

  7. AI_AUC

    Time frame: 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

    Time frame: 28 days

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

  9. Ctrough

    Time frame: 28 days

    Trough observed plasma concentration

  10. Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients

    Time frame: 28 days

    Investigation of population specific differences in PK

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 5, 2017
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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