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Trial record 50 of 69 for:    Famotidine

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

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ClinicalTrials.gov Identifier: NCT03142165
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
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 : November 29, 2017
Actual Study Completion Date : November 29, 2017

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (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:

  • 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


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): NCT03142165


Locations
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United States, California
Wcct Global, Llc
Cypress, California, United States, 90630
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03142165     History of Changes
Other Study ID Numbers: IM025-001
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
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Famotidine
Diphenhydramine
Promethazine
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Antipruritics
Dermatologic Agents
Anti-Ulcer Agents
Histamine H2 Antagonists