HealthyPhase 1NCT01115920
Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults
A Phase 1 study testing MTP-131 (Bendavia™) in people with Healthy, run by Mighty Therapeutics, Inc. at 1 site in United States.
Trial summary
This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MTP-131 (Bendavia™)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Sep 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult males or females age ≥18 years of age with signed informed consent.
- Women who are not post-menopausal or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment and who agree to use effective contraception for 30 days following the study.
Who cannot join
- Clinically significant laboratory abnormalities,
- Clinically significant abnormalities on physical examination,
- BMI of less than 18 kg/m2 or greater than 32 kg/m2,
- Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems,
- History of seizures or epilepsy,
- History of serious mental illness,
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- Participant in unrelated research involving investigational product within 30 days before planned date of drug administration,
- Positive serology for HIV 1, HIV 2, HBsAg, or HCV,
- Fever greater than 37.5°C at the time of planned dosing,
- Suspicion of or recent history of alcohol or substance abuse,
- Donated blood or blood products within the past 30 days,
- Women who are pregnant or breastfeeding,
- Employee or family member of the investigational site, and
- Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products,
- Subjects who are either unwilling to agree to refrain from use or found to be using:
- Alcohol, caffeine, xanthine-containing food or beverages, nicotine products and over-the-counter medications with the exception of Tylenol from 24 hours prior to dosing and throughout the confinement period
- Prescription medications from 14 days prior to and 7 days post treatment
- Oral contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to and 30 days post treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014-3616
About this study
Official title: A Phase I Study in Healthy Male and Healthy Female Subjects to Characterize the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MTP-131 (Bendavia™) Using a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design
This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131.
Read the detailed description
The primary objective of the study is to evaluate the safety and tolerability of MTP-131 in healthy volunteers following a single intravenous infusion. The secondary objective is to evaluate the pharmacokinetics of MTP-131. This is a double-blind, placebo-controlled, randomized trial. A total of 40 eligible subjects will be enrolled and randomized in a 3:1 active to placebo ratio for a total of 5 treatment groups of 8 volunteers. As far as is logistically possible, each treatment group will have similar numbers of male and female volunteers. After the last subject for each cohort has completed the day 3 clinical assessment and no stopping rules have been met according to Safety Review Board decision, the next cohort will commence.
- Conditions
- Healthy
- Being tested
- MTP-131 (Bendavia™)
- Keywords
- Drug Safety, Clinical Trial, Phase I, Nontherapeutic Human Experimentation, Heading Pharmacokinetics, Phase I Safety and Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTP-131 (Bendavia™)Drug
Single 4 hour intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Cohort 1, Dose 0.010 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) Receives: Drug: MTP-131 (Bendavia™) |
| Arm 2 | Experimental | Cohort 2, Dose 0.025 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) Receives: Drug: MTP-131 (Bendavia™) |
| Arm 3 | Experimental | Cohort 3, Dose 0.050 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) Receives: Drug: MTP-131 (Bendavia™) |
| Arm 4 | Experimental | Cohort 4, Dose 0.100 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) Receives: Drug: MTP-131 (Bendavia™) |
| Arm 5 | Experimental | Cohort 5, Dose 0.250 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) Receives: Drug: MTP-131 (Bendavia™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events in treatment group versus placebo group
Safety assessments including vital signs, physical exam,12-lead ECG, serum chemistry, hematology, and urinalysis will be collected the day prior to and for 7 days following study drug infusion. These parameters will be assessed for clinically significant abnormalities.
Measured: 7 days
Secondary outcomes (1)
Pharmacokinetics of MTP-131 including Css, Cmax, tmax, t½, AUC and dose proportionality.
Css (plasma steady state concentration), Cmax (observed peak plasma concentration), tmax (time of observed peak), AUC0-t (area under the plasma concentration time curve from time zero to the last quantifiable timepoint), AUC0-∞ (area under the plasma concentration time curve from time zero to infinity), λz (terminal [or elimination rate] phase rate constant), t½ (terminal half-life), CL (plasma clearance) and Vss (volume of distribution at steady state) will be determined for MTP-131. Ae (amount excreted in the urine) and CLr (renal clearance) may also be evaluated.
Measured: Pre-infusion through 32 hours post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mighty Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kenneth Lasseter, MD, Principal investigator, Clinical Pharmacology of Miami, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115920
- Sponsor's protocol ID
- SPIRI-101
- Status last verified
- Nov 2010
- First submitted
- 30 Apr 2010
- Last updated
- 18 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study in Healthy Male and Healthy Female Subjects to Characterize the Safety, Tolerability, and Pharmacokinetics of Intravenous Infusion of MTP-131 (Bendavia™) Using a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design
- ClinicalTrials.gov ID
- NCT01115920
- Acronym / sponsor ID
- SPIRI-101
- Conditions
- Healthy
- Keywords
- Drug Safety, Clinical Trial, Phase I, Nontherapeutic Human Experimentation, Heading Pharmacokinetics, Phase I Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mighty Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 May 2010 (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 is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131.
Detailed description
The primary objective of the study is to evaluate the safety and tolerability of MTP-131 in healthy volunteers following a single intravenous infusion. The secondary objective is to evaluate the pharmacokinetics of MTP-131. This is a double-blind, placebo-controlled, randomized trial. A total of 40 eligible subjects will be enrolled and randomized in a 3:1 active to placebo ratio for a total of 5 treatment groups of 8 volunteers. As far as is logistically possible, each treatment group will have similar numbers of male and female volunteers. After the last subject for each cohort has completed the day 3 clinical assessment and no stopping rules have been met according to Safety Review Board decision, the next cohort will commence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: MTP-131 (Bendavia™)Cohort 1, Dose 0.010 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) |
| Arm 2 | Experimental | Drug: MTP-131 (Bendavia™)Cohort 2, Dose 0.025 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) |
| Arm 3 | Experimental | Drug: MTP-131 (Bendavia™)Cohort 3, Dose 0.050 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) |
| Arm 4 | Experimental | Drug: MTP-131 (Bendavia™)Cohort 4, Dose 0.100 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) |
| Arm 5 | Experimental | Drug: MTP-131 (Bendavia™)Cohort 5, Dose 0.250 mg/kg/hr Active (6), Placebo (2), Total Subjects (8) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adult males or females age ≥18 years of age with signed informed consent.
- Women who are not post-menopausal or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment and who agree to use effective contraception for 30 days following the study.
Key exclusion criteria (18 listed)
- Clinically significant laboratory abnormalities,
- Clinically significant abnormalities on physical examination,
- BMI of less than 18 kg/m2 or greater than 32 kg/m2,
- Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems,
- History of seizures or epilepsy,
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 |
|---|---|---|
| MTP-131 (Bendavia™)Single 4 hour intravenous infusion | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
Primary outcome
Treatment emergent adverse events in treatment group versus placebo group
Time frame: 7 days
Safety assessments including vital signs, physical exam,12-lead ECG, serum chemistry, hematology, and urinalysis will be collected the day prior to and for 7 days following study drug infusion. These parameters will be assessed for clinically significant abnormalities.
1 secondary outcome
Pharmacokinetics of MTP-131 including Css, Cmax, tmax, t½, AUC and dose proportionality.
Time frame: Pre-infusion through 32 hours post infusion
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 18 Nov 2010.
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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 Lasseter, MD principal investigator
Clinical Pharmacology of Miami, Inc.
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 MTP-131 (Bendavia™) in people with Healthy, 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 2 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 18 Nov 2010. 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. 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?
Treatment emergent adverse events in treatment group versus placebo group (time frame: 7 days). 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 18 Nov 2010.