Healthy VolunteersPhase 1NCT01518985
The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking
A Phase 1 study testing Bendavia, Sterile saline (0.9%) and Cigarette smoking in people with Healthy Volunteers, run by Mighty Therapeutics, Inc. at 1 site in United States.
Trial summary
This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the endothelial dysfunction induced by a single cigarette. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Bendavia, Sterile saline (0.9%) and Cigarette smoking
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Mar 2012
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male smokers between 18 and 65 years of age with signed informed consent
Who cannot join
- Serum sodium level below the lower limit of sites' clinical laboratory normal range at screening, D-1 and 6
- Cholesterol level ≥ 240 mg/dL
- Hypertension (blood pressure SBP > 140, DBP > 90 mmHg)
- Body mass index < 18 or > 32 kg/m2,
- Creatinine clearance calculated by the Cockcroft and Gault method calculated to be < 90 mL/min,
- Additional laboratory abnormalities determined as clinically significant by the Principal Investigator at laboratory screening
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- Clinically significant abnormalities on physical examination,
- History or evidence of renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) system dysfunction,
- History of seizures or history of epilepsy,
- History of serious (Principal Investigator judgment) mental illness,
- Receipt of investigational medicinal product within 30 days prior to the planned date of study drug administration,
- Positive serology for human immunodeficiency virus type 1 or 2, or hepatitis B surface antigen,
- Fever > 37.5°C at the time of planned dosing,
- Suspicion, or recent history, of alcohol or substance abuse,
- Donated blood or blood products within the past 30 days,
- Employee or family member of the investigational site,
- Subjects who are either unwilling to agree to refrain from use or found to be using Nicotine (or nicotine products) including cigarettes from 12 hours prior to start of each study drug infusion through to the completion of endothelial function testing, Alcohol, Caffeine, Xanthine-containing food or beverages and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement periods, Supplementary antioxidant vitamins from 7 days prior to dosing and throughout the confinement periods, Prescription medications from 14 days prior to and 7 days post treatment
- Subjects having previous exposure to Bendavia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmaology of Miami
Miami, Florida, 33014-3616
About this study
Official title: A Phase 1, Placebo-Controlled Trial to Evaluate the Impact of Intravenous (IV) Bendavia™ (MTP-131) on Endothelial Reactivity Dysfunction Induced by Cigarette Smoking
This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the endothelial dysfunction induced by a single cigarette.
- Conditions
- Healthy Volunteers
- Being tested
- Bendavia, Sterile saline (0.9%), Cigarette smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendaviaDrug
Bendavia for infusion Intravenous infusion (0.25mg/kg/hr) for 4 hours
Sterile saline (0.9%)Drug
Sterile saline for infusion (0.9%) Intravenous infusion for 4 hours
Cigarette smokingOther
One unfiltered cigarette will be smoked at approximately 30 minutes post-study-drug administration start.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intravenous infusion of saline (0.9%) for 4 hours with smoking of one unfiltered cigarette at 30 minutes post-study-drug administration start Receives: Drug: Sterile saline (0.9%); Other: Cigarette smoking |
| Bendavia | Experimental | Intravenous infusion of Bendavia (0.25mg/kg/hr) for 4 hours with smoking of one unfiltered cigarette at 30 minutes post-study-drug administration start Receives: Drug: Bendavia; Other: Cigarette smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of variance (ANOVA) between group mean endothelial function (EndoPAT Index) following smoking a single cigarette with and without Bendavia
Endothelial function will be determined using EndoPAT 2000 (Itamar Medical Ltd) prior to and after smoking of one unfiltered cigarette and prior to and after initiation of study drug. Group comparison of endothelial function (EndoPAT Index) between placebo and active study drug within a subject will be performed.
EndoPAT quantifies the endothelium-mediated changes in vascular tone. A post-occlusion to pre-occlusion ratio is calculated providing the EndoPAT index.
Measured: Baseline, +30, +60, +90 minutes post-study-drug administration start
Secondary outcomes (5)
Anova between group mean inflammatory laboratory marker (hs-CRP; mg/L) after smoking one cigarette with and without Bendavia
hs-CRP will be evaluated prior to and after smoking of one unfiltered cigarette and prior to and after initiation of study drug. Group comparison of hs-CRP levels between placebo and active study drug within a subject will be performed.
Measured: Baseline to 24 hours post-study-drug administration
ANOVA between group means of urinary 8-isoprostane (ng/mg of creatinine) after smoking one cigarette with and without Bendavia
8-isoprostane will be measured prior to and after smoking of one unfiltered cigarette and prior to and after initiation of study drug. Group comparison of laboratory results between placebo and active study drug within a subject will be performed.
Measured: Baseline to 48 hours post-study-drug administration
Number adverse events with and without Bendavia
Adverse events will be tabulated by treatment group. No statistical analysis will be preformed.
Measured: Baseline to Study Day 10
Assessment of Bendavia exposure measured by area Under the Curve (AUC; ng*hr/mL)
Bendavia levels will be measured and pharmacokinetic parameters reported.
Measured: Baseline to 48 hours post-study-drug administration
ANOVA between group means of urinary 8-hydroxy-2'-deoxyguanosine (pg/mL) after smoking one cigarette with and without Bendavia
8-hydroxy-2'-deoxyguanosine will be measured prior to and after smoking of one unfiltered cigarette and prior to and after initiation of study drug. Group comparison of laboratory results between placebo and active study drug within a subject will be performed.
Measured: Baseline to 48 hours post-study-drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mighty Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth C Lasseter, MD, Principal investigator, Clinical Pharmacology of MiamiRichard Straube, MD, Study director, Stealth Peptides
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518985
- Sponsor's protocol ID
- SPIRI-120
- Status last verified
- Apr 2012
- First submitted
- 23 Jan 2012
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-Controlled Trial to Evaluate the Impact of Intravenous (IV) Bendavia™ (MTP-131) on Endothelial Reactivity Dysfunction Induced by Cigarette Smoking
- ClinicalTrials.gov ID
- NCT01518985
- Acronym / sponsor ID
- SPIRI-120
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mighty Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Jan 2012 (estimated)
- 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.
This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the endothelial dysfunction induced by a single cigarette.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Sterile saline (0.9%), Other: Cigarette smokingIntravenous infusion of saline (0.9%) for 4 hours with smoking of one unfiltered cigarette at 30 minutes post-study-drug administration start |
| Bendavia | Experimental | Drug: Bendavia, Other: Cigarette smokingIntravenous infusion of Bendavia (0.25mg/kg/hr) for 4 hours with smoking of one unfiltered cigarette at 30 minutes post-study-drug administration start |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult male smokers between 18 and 65 years of age with signed informed consent
Key exclusion criteria (18 listed)
- Serum sodium level below the lower limit of sites' clinical laboratory normal range at screening, D-1 and 6
- Cholesterol level ≥ 240 mg/dL
- Hypertension (blood pressure SBP > 140, DBP > 90 mmHg)
- Body mass index < 18 or > 32 kg/m2,
- Creatinine clearance calculated by the Cockcroft and Gault method calculated to be < 90 mL/min,
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 |
|---|---|---|
| BendaviaBendavia for infusion Intravenous infusion (0.25mg/kg/hr) for 4 hours | Drug | Bendavia |
| Sterile saline (0.9%)Sterile saline for infusion (0.9%) Intravenous infusion for 4 hours | Drug | Placebo |
| Cigarette smokingOne unfiltered cigarette will be smoked at approximately 30 minutes post-study-drug administration start. | Other | Bendavia, Placebo |
Primary outcome
Analysis of variance (ANOVA) between group mean endothelial function (EndoPAT Index) following smoking a single cigarette with and without Bendavia
Time frame: Baseline, +30, +60, +90 minutes post-study-drug administration start
Endothelial function will be determined using EndoPAT 2000 (Itamar Medical Ltd) prior to and after smoking of one unfiltered cigarette and prior to and after initiation of study drug. Group comparison of endothelial function (EndoPAT Index) between placebo and active study drug within a subject will be performed. EndoPAT quantifies the endothelium-mediated changes in vascular tone. A post-occlusion to pre-occlusion ratio is calculated providing the EndoPAT index.
5 secondary outcomes
Anova between group mean inflammatory laboratory marker (hs-CRP; mg/L) after smoking one cigarette with and without Bendavia
Time frame: Baseline to 24 hours post-study-drug administration
ANOVA between group means of urinary 8-isoprostane (ng/mg of creatinine) after smoking one cigarette with and without Bendavia
Time frame: Baseline to 48 hours post-study-drug administration
Number adverse events with and without Bendavia
Time frame: Baseline to Study Day 10
Assessment of Bendavia exposure measured by area Under the Curve (AUC; ng*hr/mL)
Time frame: Baseline to 48 hours post-study-drug administration
ANOVA between group means of urinary 8-hydroxy-2'-deoxyguanosine (pg/mL) after smoking one cigarette with and without Bendavia
Time frame: Baseline to 48 hours post-study-drug administration
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 19 Apr 2012.
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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.
Kenneth C Lasseter, MD principal investigator
Clinical Pharmacology of Miami
Richard Straube, MD study director
Stealth Peptides
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bendavia, Sterile saline (0.9%) and Cigarette smoking in people with Healthy Volunteers, run by Mighty Therapeutics, Inc. at 1 site in United States.
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 1 inclusion and 18 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 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Analysis of variance (ANOVA) between group mean endothelial function (EndoPAT Index) following smoking a single cigarette with and without Bendavia (time frame: Baseline, +30, +60, +90 minutes post-study-drug administration start). 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 19 Apr 2012.