Clinical trial NCT03241264: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fibrosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Nitto Denko Corporation
First posted: 2017-08-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: Up to 28 days
measure: Time to maximum plasma concentration (Tmax)
timeFrame: Up to 28 days
measure: Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)
timeFrame: Up to 28 days
measure: Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
timeFrame: Up to 28 days
measure: Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)
timeFrame: Up to 28 days
measure: Apparent first-order terminal elimination rate constant (Kel)
timeFrame: Up to 28 days
measure: Volume of distribution during the elimination phase after IV administration (Vz)
timeFrame: Up to 28 days
measure: Apparent volume of distribution at steady-state (Vss)
timeFrame: Up to 28 days
measure: Total plasma clearance of drug after IV administration (CL/F)
timeFrame: Up to 28 days
measure: Apparent first-order terminal elimination half-life (T1/2)
timeFrame: Up to 28 days
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 28 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 28 days
measure: Incidence of discontinuations of study drug due to toxicity
timeFrame: Up to 28 days
Other outcomes:
Locations:
Study officials:
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