HealthyPhase 1NCT01754818
A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)
A Phase 1 study testing Bendavia 10mg, Bendavia 50mg and Bendavia 100mg in people with Healthy, run by Mighty Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the study medication blood levels after administration of a single oral capsule of Bendavia at one of three dose levels. The effects of Bendavia on the volunteers will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bendavia 10mg, Bendavia 50mg and Bendavia 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Feb 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult males or females aged between 18 and 65 years of age with signed informed consent.
- Women who are not post-menopausal (without menstrual bleed for >24 months) or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment with understanding (through informed consent process) to not become pregnant over the duration of the study and must agree to employ an effective form of birth control for the duration of the study.
- Acceptable forms of birth control are: double-barrier contraceptives (condom, diaphragm with spermicide) or intra-uterine device 1 week prior to and at least 30 days post treatment even if hormonal contraceptives are used.
Who cannot join
- Serum sodium level below the lower limit of the site's clinical laboratory normal range at the study qualification visit,
- Clinically significant laboratory abnormalities as determined by the Principal Investigator at laboratory screening
- Creatinine clearance calculated by the Cockcroft and Gault method calculated to be <90 mL/min for males and <80 mL/min for females
- Clinically significant abnormalities on physical examination,
- Body weight less than 60 or greater than 80 kg and a body mass index 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,
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- History of seizures or history of epilepsy,
- History of serious (Principal Investigator judgment) mental illness,
- Participant in any research involving investigational product within 30 days before planned date of drug administration,
- Positive serology for human immunodeficiency virus type 1 or 2, hepatitis B surface antigen, or hepatitis C,
- Fever greater than 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,
- Women who are pregnant or breastfeeding,
- Employee or family member of the investigational site,
- Subjects who currently smoke cigarettes, cigars, pipes or chew tobacco products or who have used any tobacco product in the 30 days prior to screening,
- 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, dose (excluding hormonal contraceptives)
- Hormonal contraceptives without concomitant use of double-barrier contraceptives (condom, diaphragm with spermicide) for a period of 7 days prior to, and 30 days post, dose
- Subjects having previous exposure to Bendavia
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami
Miami, Florida, 33014
About this study
Official title: Phase 1 Randomized, Double-blind, Placebo-controlled Study of The Safety, Tolerability and Pharmacokinetics of Single, Ascending Oral Doses Of Bendavia in Healthy Volunteers
The purpose of this study is to assess the study medication blood levels after administration of a single oral capsule of Bendavia at one of three dose levels. The effects of Bendavia on the volunteers will also be assessed.
- Conditions
- Healthy
- Being tested
- Bendavia 10mg, Bendavia 50mg, Bendavia 100mg, Placebo
- Keywords
- Pharmacokinetics, volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bendavia 10mgDrug
Bendavia 50mgDrug
Bendavia 100mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, oral capsule, no active study drug, single dose Receives: Drug: Placebo |
| Bendavia 10mg | Experimental | Bendavia, oral capsule, 10mg, single dose Receives: Drug: Bendavia 10mg; Drug: Placebo |
| Bendavia 50mg | Experimental | Bendavia, oral capsule, 50mg, single dose Receives: Drug: Bendavia 50mg; Drug: Placebo |
| Bendavia 100mg | Experimental | Bendavia, oral capsule, 100mg, single dose Receives: Drug: Bendavia 100mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean peak plasma concentration (Cmax) of Bendavia (ng/ml) in each cohort.
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. Mean Cmax is defined as the mean of maximum concentration reported for each subject by cohort.
Measured: Immediately prior to dosing (0hr) to 48 hours post-dose
Mean Area Under the Curve (AUC) for Bendavia (hr.ng/ml) in the time from dosing to final plasma sample in each cohort.
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. AUC (0-last) will be calculated using validated pharmacokinetic analysis software and mean AUC for Bendavia is defined as the mean of AUC (0-last) reported for each subject by cohort.
Measured: Immediately prior to dosing (0hr) to 48 hours post-dose
Mean Time post-dose of the peak plasma concentration (Tmax) of Bendavia (hours) in each cohort.
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. Mean Tmax is defined as the mean of time to reach maximum plasma concentration reported for each subject by cohort.
Measured: Immediately prior to dosing (0hr) to 48 hours post-dose
Mean apparent clearance (CL/F) of Bendavia (ml/hr/kg) in each cohort.
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. CL/F will be calculated using validated pharmacokinetic analysis software and mean CL/F for Bendavia is defined as the mean of CL/F reported for each subject by cohort.
Measured: Immediately prior to dosing (0hr) to 48 hours post-dose
Mean Volume of Distribution (Vd/F) of Bendavia (ml/kg) in each cohort.
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. Vd/F will be calculated using validated pharmacokinetic analysis software and mean Vd/F for Bendavia is defined as the mean of Vd/F reported for each subject by cohort.
Measured: Immediately prior to dosing (0hr) to 48 hours post-dose
Mean Half Life(t1/2) of Bendavia (hours) in each cohort.
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. t1/2 will be calculated using validated pharmacokinetic analysis software and mean t1/2 for Bendavia is defined as the mean of t1/2 reported for each subject by cohort.
Measured: Immediately prior to dosing (0hr) to 48 hours post-dose
Secondary outcomes (6)
Mean Area Under the Curve (AUC) for Bendavia metabolite M1 (hr.ng/ml) in the time from dosing to final plasma sample in each cohort.
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia metabolite M1 plasma concentrations. AUC (0-last) will be calculated using validated pharmacokinetic analysis software and mean AUC for Bendavia metabolite M1 is defined as the mean of AUC (0-last) reported for each subject by cohort.
Measured: Immediately prior to dosing (0hr) to 48 hours post-dose
Mean Area Under the Curve (AUC) for Bendavia metabolite M2 (hr.ng/ml) in the time from dosing to final plasma sample in each cohort.
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia metabolite M2 plasma concentrations. AUC (0-last) will be calculated using validated pharmacokinetic analysis software and mean AUC for Bendavia metabolite M2 is defined as the mean of AUC (0-last) reported for each subject by cohort.
Measured: Immediately prior to dosing (0hr) to 48 hours post-dose
Mean change in concentration of urinary 8-isoprostane (pg/mg creatinine) from pre-dose through to 48 hours post-dose for each cohort.
Spot urine samples will be collected at pre-dose, 12, 24 and 48 hours post-dose for assay of 8-isoprostane (8-EPIPGF2a) and creatinine. Change from baseline value at each time point assessed will be calculated for each subject. Mean change from baseline is defined as the mean of the change in 8-EPIPGF2a/creatinine for each subject by cohort.
Measured: Prior to dosing (0hr) to 48 hours post-dose
Mean change in concentration of urinary 8-hydroxy-2-deoxyguanosine (ng/mg creatinine) from pre-dose through to 48 hours post-dose for each cohort.
Spot urine samples will be collected at pre-dose, 12, 24 and 48 hours post-dose for assay of 8- hydroxy-2-deoxyguanosine (8-OHDG) and creatinine. Change from baseline value at each time point assessed will be calculated for each subject. Mean change from baseline is defined as the mean of the change in 8-OHDG/creatinine for each subject by cohort.
Measured: Prior to dosing (0hr) to 48 hours post-dose
Number of adverse events observed with and without Bendavia
Adverse events will be tabulated by treatment group. No statistical analysis will be performed.
Measured: From time of study drug administration to End of Study (Day 3)
Mean change from baseline in High Sensitivity C-Reactive Protein (hs-CRP; ng/L) through 48 hours post-dose.
hs-CRP will be evaluated prior to (Baseline) and after (12, 24 and 48 hours) study drug administration. Change from baseline value at each time point assessed will be calculated for each subject. Mean change from baseline is defined as the mean of the change in hs-CRP for each subject by cohort.
Measured: Pre-dose to 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionFeb 2013
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 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, Mighty Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754818
- Sponsor's protocol ID
- SPIO-101
- Status last verified
- Feb 2013
- First submitted
- 18 Dec 2012
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Randomized, Double-blind, Placebo-controlled Study of The Safety, Tolerability and Pharmacokinetics of Single, Ascending Oral Doses Of Bendavia in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01754818
- Acronym / sponsor ID
- SPIO-101
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mighty Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 21 Dec 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.
The purpose of this study is to assess the study medication blood levels after administration of a single oral capsule of Bendavia at one of three dose levels. The effects of Bendavia on the volunteers will also be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, oral capsule, no active study drug, single dose |
| Bendavia 10mg | Experimental | Drug: Bendavia 10mg, Drug: PlaceboBendavia, oral capsule, 10mg, single dose |
| Bendavia 50mg | Experimental | Drug: Bendavia 50mg, Drug: PlaceboBendavia, oral capsule, 50mg, single dose |
| Bendavia 100mg | Experimental | Drug: Bendavia 100mg, Drug: PlaceboBendavia, oral capsule, 100mg, single dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult males or females aged between 18 and 65 years of age with signed informed consent.
- Women who are not post-menopausal (without menstrual bleed for >24 months) or surgically sterile must have a negative serum pregnancy test at screening and within 24 hours of treatment with understanding (through informed consent process) to not become pregnant over the duration of the study and must agree to employ an effective form of birth control for the duration of the study.
- Acceptable forms of birth control are: double-barrier contraceptives (condom, diaphragm with spermicide) or intra-uterine device 1 week prior to and at least 30 days post treatment even if hormonal contraceptives are used.
Key exclusion criteria (21 listed)
- Serum sodium level below the lower limit of the site's clinical laboratory normal range at the study qualification visit,
- Clinically significant laboratory abnormalities as determined by the Principal Investigator at laboratory screening
- Creatinine clearance calculated by the Cockcroft and Gault method calculated to be <90 mL/min for males and <80 mL/min for females
- Clinically significant abnormalities on physical examination,
- Body weight less than 60 or greater than 80 kg and a body mass index of less than 18 kg/m2 or greater than 32 kg/m2,
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 |
|---|---|---|
| Bendavia 10mg | Drug | Bendavia 10mg |
| Bendavia 50mg | Drug | Bendavia 50mg |
| Bendavia 100mg | Drug | Bendavia 100mg |
| Placebo | Drug | Bendavia 100mg, Bendavia 10mg, Bendavia 50mg, Placebo |
Primary outcome
Mean peak plasma concentration (Cmax) of Bendavia (ng/ml) in each cohort.
Time frame: Immediately prior to dosing (0hr) to 48 hours post-dose
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. Mean Cmax is defined as the mean of maximum concentration reported for each subject by cohort.
Mean Area Under the Curve (AUC) for Bendavia (hr.ng/ml) in the time from dosing to final plasma sample in each cohort.
Time frame: Immediately prior to dosing (0hr) to 48 hours post-dose
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. AUC (0-last) will be calculated using validated pharmacokinetic analysis software and mean AUC for Bendavia is defined as the mean of AUC (0-last) reported for each subject by cohort.
Mean Time post-dose of the peak plasma concentration (Tmax) of Bendavia (hours) in each cohort.
Time frame: Immediately prior to dosing (0hr) to 48 hours post-dose
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. Mean Tmax is defined as the mean of time to reach maximum plasma concentration reported for each subject by cohort.
Mean apparent clearance (CL/F) of Bendavia (ml/hr/kg) in each cohort.
Time frame: Immediately prior to dosing (0hr) to 48 hours post-dose
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. CL/F will be calculated using validated pharmacokinetic analysis software and mean CL/F for Bendavia is defined as the mean of CL/F reported for each subject by cohort.
Mean Volume of Distribution (Vd/F) of Bendavia (ml/kg) in each cohort.
Time frame: Immediately prior to dosing (0hr) to 48 hours post-dose
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. Vd/F will be calculated using validated pharmacokinetic analysis software and mean Vd/F for Bendavia is defined as the mean of Vd/F reported for each subject by cohort.
Mean Half Life(t1/2) of Bendavia (hours) in each cohort.
Time frame: Immediately prior to dosing (0hr) to 48 hours post-dose
Blood drawn at pre-dose (immediately prior to study drug ingestion), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose will be assessed for Bendavia plasma concentrations. t1/2 will be calculated using validated pharmacokinetic analysis software and mean t1/2 for Bendavia is defined as the mean of t1/2 reported for each subject by cohort.
6 secondary outcomes
Mean Area Under the Curve (AUC) for Bendavia metabolite M1 (hr.ng/ml) in the time from dosing to final plasma sample in each cohort.
Time frame: Immediately prior to dosing (0hr) to 48 hours post-dose
Mean Area Under the Curve (AUC) for Bendavia metabolite M2 (hr.ng/ml) in the time from dosing to final plasma sample in each cohort.
Time frame: Immediately prior to dosing (0hr) to 48 hours post-dose
Mean change in concentration of urinary 8-isoprostane (pg/mg creatinine) from pre-dose through to 48 hours post-dose for each cohort.
Time frame: Prior to dosing (0hr) to 48 hours post-dose
Mean change in concentration of urinary 8-hydroxy-2-deoxyguanosine (ng/mg creatinine) from pre-dose through to 48 hours post-dose for each cohort.
Time frame: Prior to dosing (0hr) to 48 hours post-dose
Number of adverse events observed with and without Bendavia
Time frame: From time of study drug administration to End of Study (Day 3)
Mean change from baseline in High Sensitivity C-Reactive Protein (hs-CRP; ng/L) through 48 hours post-dose.
Time frame: Pre-dose to 48 hours post-dose
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 6 Feb 2013.
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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
Mighty Therapeutics, 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 Bendavia 10mg, Bendavia 50mg and Bendavia 100mg 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 3 inclusion and 21 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 6 Feb 2013. 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?
Mean peak plasma concentration (Cmax) of Bendavia (ng/ml) in each cohort. (time frame: Immediately prior to dosing (0hr) to 48 hours post-dose). The study lists 6 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 6 Feb 2013.