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A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body

Primary Purpose

Fibrosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ND-L02-s0201
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fibrosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is in good health, as determined by the Investigator
  • Subject consumes an average of no more than 2 alcoholic drinks per day within the 6 months before administration of study drug
  • Subject has serum calcium and parathyroid hormone (intact) within the limits of the normal range of the laboratory

Exclusion Criteria:

  • Subject has a disease or condition (medical or surgical) which, in the opinion of the Investigator, may compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous systems; or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of ND-L02-s0201 solution, or that may place the subject at increased risk
  • Subject has a history of bone disease, including osteoporosis and osteomalacia, Paget's disease of bone, or a history of unexplained fractures or fractures after minimal trauma
  • Subject has abnormal laboratory values considered to be clinically significant by the Investigator

Other protocol inclusion/exclusion criteria may apply

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Module A

    Module B

    Arm Description

    Lyophilized Formulation

    Frozen Formulation

    Outcomes

    Primary Outcome Measures

    Maximum plasma concentration (Cmax)
    Time to maximum plasma concentration (Tmax)
    Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)
    Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
    Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)
    Apparent first-order terminal elimination rate constant (Kel)
    Volume of distribution during the elimination phase after IV administration (Vz)
    Apparent volume of distribution at steady-state (Vss)
    Total plasma clearance of drug after IV administration (CL/F)
    Apparent first-order terminal elimination half-life (T1/2)

    Secondary Outcome Measures

    Incidence of adverse events (AEs)
    Incidence of serious adverse events (SAEs)
    Incidence of discontinuations of study drug due to toxicity

    Full Information

    First Posted
    August 3, 2017
    Last Updated
    August 3, 2017
    Sponsor
    Bristol-Myers Squibb
    Collaborators
    Nitto Denko Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03241264
    Brief Title
    A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body
    Official Title
    A Phase 1, Open-Label, Randomized-Sequence, Single-Crossover, Bridging Study to Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Two ND-L02-s0201 Formulations, Frozen Versus Lyophilized, Administered by Intravenous Infusion to Healthy Male and Female Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 28, 2016 (Actual)
    Primary Completion Date
    October 21, 2016 (Actual)
    Study Completion Date
    October 21, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bristol-Myers Squibb
    Collaborators
    Nitto Denko Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibrosis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Module A
    Arm Type
    Experimental
    Arm Description
    Lyophilized Formulation
    Arm Title
    Module B
    Arm Type
    Experimental
    Arm Description
    Frozen Formulation
    Intervention Type
    Drug
    Intervention Name(s)
    ND-L02-s0201
    Intervention Description
    Specified dose on specified day
    Primary Outcome Measure Information:
    Title
    Maximum plasma concentration (Cmax)
    Time Frame
    Up to 28 days
    Title
    Time to maximum plasma concentration (Tmax)
    Time Frame
    Up to 28 days
    Title
    Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)
    Time Frame
    Up to 28 days
    Title
    Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
    Time Frame
    Up to 28 days
    Title
    Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)
    Time Frame
    Up to 28 days
    Title
    Apparent first-order terminal elimination rate constant (Kel)
    Time Frame
    Up to 28 days
    Title
    Volume of distribution during the elimination phase after IV administration (Vz)
    Time Frame
    Up to 28 days
    Title
    Apparent volume of distribution at steady-state (Vss)
    Time Frame
    Up to 28 days
    Title
    Total plasma clearance of drug after IV administration (CL/F)
    Time Frame
    Up to 28 days
    Title
    Apparent first-order terminal elimination half-life (T1/2)
    Time Frame
    Up to 28 days
    Secondary Outcome Measure Information:
    Title
    Incidence of adverse events (AEs)
    Time Frame
    Up to 28 days
    Title
    Incidence of serious adverse events (SAEs)
    Time Frame
    Up to 28 days
    Title
    Incidence of discontinuations of study drug due to toxicity
    Time Frame
    Up to 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject is in good health, as determined by the Investigator Subject consumes an average of no more than 2 alcoholic drinks per day within the 6 months before administration of study drug Subject has serum calcium and parathyroid hormone (intact) within the limits of the normal range of the laboratory Exclusion Criteria: Subject has a disease or condition (medical or surgical) which, in the opinion of the Investigator, may compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous systems; or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of ND-L02-s0201 solution, or that may place the subject at increased risk Subject has a history of bone disease, including osteoporosis and osteomalacia, Paget's disease of bone, or a history of unexplained fractures or fractures after minimal trauma Subject has abnormal laboratory values considered to be clinically significant by the Investigator Other protocol inclusion/exclusion criteria may apply

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body

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