FibrosisPhase 1NCT03241264
A Study of Safety, Tolerability, and the Effects Two ND-L02-s0201 Have on the Body
A Phase 1 study testing ND-L02-s0201 in people with Fibrosis, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrosis
- What is being tested?
- ND-L02-s0201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2016to 21 Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body
- Conditions
- Fibrosis
- Being tested
- ND-L02-s0201
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ND-L02-s0201Drug
Specified dose on specified day
| Study group | Role | What they receive |
|---|---|---|
| Module A | Experimental | Lyophilized Formulation Receives: Drug: ND-L02-s0201 |
| Module B | Experimental | Frozen Formulation Receives: Drug: ND-L02-s0201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: Up to 28 days
Time to maximum plasma concentration (Tmax)
Measured: Up to 28 days
Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)
Measured: Up to 28 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
Measured: Up to 28 days
Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)
Measured: Up to 28 days
Apparent first-order terminal elimination rate constant (Kel)
Measured: Up to 28 days
Volume of distribution during the elimination phase after IV administration (Vz)
Measured: Up to 28 days
Apparent volume of distribution at steady-state (Vss)
Measured: Up to 28 days
Total plasma clearance of drug after IV administration (CL/F)
Measured: Up to 28 days
Apparent first-order terminal elimination half-life (T1/2)
Measured: Up to 28 days
Secondary outcomes (3)
Incidence of adverse events (AEs)
Measured: Up to 28 days
Incidence of serious adverse events (SAEs)
Measured: Up to 28 days
Incidence of discontinuations of study drug due to toxicity
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start28 Aug 2016
- Primary completion21 Oct 2016
- Study completion21 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nitto Denko Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241264
- Sponsor's protocol ID
- ND-L02-s0201-004
- Status last verified
- Jul 2017
- First submitted
- 3 Aug 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03241264
- Acronym / sponsor ID
- ND-L02-s0201-004
- Conditions
- Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Nitto Denko Corporation
- Study start
- 28 Aug 2016 (actual)
- Primary completion
- 21 Oct 2016 (actual)
- Study completion
- 21 Oct 2016 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, and the effects two ND-L02-s0201 have on the body
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Module A | Experimental | Drug: ND-L02-s0201Lyophilized Formulation |
| Module B | Experimental | Drug: ND-L02-s0201Frozen Formulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ND-L02-s0201Specified dose on specified day | Drug | Module A, Module B |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: Up to 28 days
Time to maximum plasma concentration (Tmax)
Time frame: Up to 28 days
Area under the plasma concentration-time curve from time 0 to the last available observable concentration (AUC0-t)
Time frame: Up to 28 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
Time frame: Up to 28 days
Area under the first moment of the plasma concentration-time curve from time zero to infinity (AUMC0-inf)
Time frame: Up to 28 days
Apparent first-order terminal elimination rate constant (Kel)
Time frame: Up to 28 days
Volume of distribution during the elimination phase after IV administration (Vz)
Time frame: Up to 28 days
Apparent volume of distribution at steady-state (Vss)
Time frame: Up to 28 days
Total plasma clearance of drug after IV administration (CL/F)
Time frame: Up to 28 days
Apparent first-order terminal elimination half-life (T1/2)
Time frame: Up to 28 days
3 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 28 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 28 days
Incidence of discontinuations of study drug due to toxicity
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ND-L02-s0201 in people with Fibrosis, run by Bristol-Myers Squibb.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) (time frame: Up to 28 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2017.