HealthyPhase 1NCT02486055
A Safety Study of Orally Administered BPM31510 in Healthy Subjects
A Phase 1 study testing BPM31510 Oral Nanosuspension 4% in people with Healthy, run by BPGbio at 1 site in United States.
Trial summary
This is an open-label, Phase I study of the bioavailability and safety of BPM31510 in healthy subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600 mg as a single administration. 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?
- BPM31510 Oral Nanosuspension 4%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jan 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Men and women, age >18 years
- Body mass index (BMI)≥19 and ≤30
- Good health conditions or without significant illness, by judgment of a legally qualified professional, according to the following evaluations: medical history, physical examination, vital signs, electrocardiogram (ECG), and screening or baseline hematology and clinical chemistry measures.
- Subjects of child bearing potential must agree to use one of the accepted methods of contraception (listed below) during the trial (including the screening period prior to receiving trial medication), at least until return of menstruation after stopping the trial medication.
- condom (male or female) with spermicide,
- diaphragm or cervical cap with spermicide
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- Intrauterine device (IUD)
- hormonal contraception and condom (male or female)
- The following subjects are not required to use contraception:
- Subjects who practice total abstinence from sexual intercourse as the preferred lifestyle (periodic abstinence is not acceptable)
- Female subjects with partners or male subjects who had been vasectomized at least 3 months before screening.
- Postmenopausal females who have not experienced menstruation for at least 2 years based on medical history
- Female subjects who are surgically sterile (ie, bilateral oophorectomy, hysterectomy or bilateral tubal ligation) at least 3 months before screening) based on medical history.
- Female subjects must have a negative pregnancy test result at screening and Day-1
- PT/PTT/INR within normal limits
- Vitamin K levels within normal limits
- Capable of understanding and complying with the protocol and signing informed consent.
Who cannot join
- Pregnant or lactating female subjects.
- Known hypersensitivity to the study drug (Coenzyme Q10) or to compounds chemically related.
- History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes with the drug's absorption, distribution, excretion or metabolism.
- History of hepatic, renal, pulmonary, gastrointestinal, epileptic, hematologic or psychiatric illness.
- Hypotension or hypertension of any etiologic that needs pharmacologic treatment.
- History of or existing coagulopathy.
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- History of myocardial infarction, angina, and/or heart insufficiency.
- Non-recommended electrocardiographic findings, according to investigator criteria.
- Results of the laboratory exams out of normal range unless that they are considered as clinically irrelevant by the investigator.
- Subject is a smoker.
- Subject ingests more than 5 cups of coffee or tea a day.
- History of alcohol or drug abuse.
- History of serious adverse reactions or hypersensitivity to any drug.
- On-going regular use of oral prescription drugs, with the exception of oral contraceptives.
- Hospitalization for any reason within 8 weeks prior to study dosing.
- Participation in any experimental study or ingested any experimental drug within 30 days preceding study.
- Donation or loss of 450 mL or more of blood within the 3 months prior to Screening/Baseline.
- Subject consumed alcohol 48 hours prior to the baseline measurements of the study.
- Subject reports history of human immunodeficiency virus.
- Currently using coenzyme Q10 over-the-counter products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Orally Administered BPM 31510 in Healthy Subjects
This is an open-label, Phase I study of the bioavailability and safety of BPM31510 in healthy subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600 mg as a single administration. Cohort 1 and Cohort 2 will consist of 10 patients each. The cohorts may be enrolled sequentially.
Read the detailed description
This is an open-label, Phase I study of the bioavailability and safety of Berg Pharma Molecule 31510 (BPM31510) in healthy subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600 mg as a single administration. Cohort 1 and Cohort 2 will consist of 10 patients each. Men and women over the age of 18, and in good general health, will undergo Screening and baseline evaluations up to 21 days prior to dosing. The cohorts may be enrolled sequentially. Subjects will be admitted to the clinic on Day 0.
All subjects will self-administer the all Day 1 doses of study drug under supervision of the clinic staff. In the pre-study cohort, subjects will be administered a single dose of 1600 mg. In Cohort 1, doses will be administered two times per day before the morning and evening meals with no less than 8 and no more than 10 hours between doses. Immediately after administration, subjects will ingest 6 ounces of tap or bottled water. Solid food and drinks, other than water should be restricted to 2 hours before and 1 hour after dosing. In Cohort 2 doses will be administered three times per day before meals, with no less than 4 and no more than 6 hours between doses. Immediately after administration, subjects will ingest 6 ounces of tap or bottled water. Solid food and drinks, other than water should be restricted to 2 hours before and 1 hour after dosing. Dosing will continue for an additional 4 days on an outpatient basis with the last study dose to be administered at the clinic on Day 5 (only morning dose is given on Day 5).
For the pre-study cohort, subjects will be administered a single dose of 1600 mg before breakfast. PK and PD sampling will be performed 30 minutes prior to dosing, and 0.5, 1, 2 and 4 hours later. Subjects will be evaluated for any untoward signs or symptoms and will be discharged. For cohorts 1 and 2, on Days 1, 2,and 5, pharmacokinetic (PK) and pharmacodynamics (PD) sampling will be performed 30 minutes prior to the first dose, and 0.5, 1, 2, and 4 hours after the first dose at all visits for BID and TID (with an additional PK draw on Day 1 at 0.5, 1, 2, and 4 after the second dose of TID subjects only). Urine for PK/PD will be collected pre-dose on Day 1, Day 2, and Day 5. At all visits (on Days 1, 2,and at the final dose on Day5), samples will be collected for chemistry, CBC, INR, PT, PTT, cholesterol, LDL, and HDL, and vitamin K level. Blood samples for PK/PD will be collected 30 minutes prior to the last dose (AM) on Day 5 and also at 0.5, 1, 2, and 4 hours after dosing. Lab samples (chemistry, etc.), as above will also be drawn at the time of the first PK/PD draw on Day 5.
A phone interview will be conducted no fewer than 25 days and no more than 35 days after the last dose on Day 5 to collect information on concomitant medications and adverse events (AEs).
- Conditions
- Healthy
- Being tested
- BPM31510 Oral Nanosuspension 4%
- Keywords
- Study safety of BPM31510 in healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPM31510 Oral Nanosuspension 4%Drug
Also called Coenzyme Q10, CoQ10, ubidecarenone
Oral nanosuspension formulation of BPM31510 (ubidecarenone, USP)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | In Cohort 1, doses of BPM31510 Oral Nanosuspension 4% will be administered two times per day before the morning and evening meals with no less than 8 and no more than 10 hours between doses. Immediately after administration, subjects will ingest 6 ounces of tap or bottled water. Solid food and drinks, other than water should be restricted to 2 hours before and 1 hour after dosing. Receives: Drug: BPM31510 Oral Nanosuspension 4% |
| Cohort 2 | Active comparator | In Cohort 2 doses BPM31510 Oral Nanosuspension 4% will be administered three times per day before meals, with no less than 4 and no more than 6 hours between doses. Immediately after administration, subjects will ingest 6 ounces of tap or bottled water. Solid food and drinks, other than water should be restricted to 2 hours before and 1 hour after dosing. Receives: Drug: BPM31510 Oral Nanosuspension 4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
PK parameters maximum plasma concentration (Cmax) and area under the plasma concentration curve from 0 to 4 hours (AUC0-4) on Days 1, 2, 8, and 15; baseline pre-dosing concentrations.
Measured: Days 1, 2, 8, and 15; baseline pre-dosing concentrations
Secondary outcomes (2)
Blood sample analysis as a measure of safety and tolerability
Complete blood count, INR/PT/PTT, comprehensive chemistry panel, international normalized ratio (INR), liver function tests, vitamin K levels, AEs, C-reactive protein, cholesterol, LDL, HDL for investigative purposes.
Measured: Days 1, 2, 8, and 15; baseline pre-dosing concentrations
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
A follow-up phone interview with each study subject will occur 30 to 45 days after the end of dosing to measure the number of adverse events that have occurred.
Measured: 30 to 45 days after the end of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionJan 2016
- Study completionJan 2016
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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BPGbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Magdy Shenouda, MD, Principal investigator, Clinilabs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486055
- Sponsor's protocol ID
- BP 0312-01
- Status last verified
- Jan 2016
- First submitted
- 4 Dec 2014
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Orally Administered BPM 31510 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02486055
- Acronym / sponsor ID
- BP 0312-01
- Conditions
- Healthy
- Keywords
- Study safety of BPM31510 in healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BPGbioIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Jul 2015 (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 an open-label, Phase I study of the bioavailability and safety of BPM31510 in healthy subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600 mg as a single administration. Cohort 1 and Cohort 2 will consist of 10 patients each. The cohorts may be enrolled sequentially.
Detailed description
This is an open-label, Phase I study of the bioavailability and safety of Berg Pharma Molecule 31510 (BPM31510) in healthy subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving a single dose (pre-study cohort). The pre-study cohort subjects will receive 1600 mg as a single administration. Cohort 1 and Cohort 2 will consist of 10 patients each. Men and women over the age of 18, and in good general health, will undergo Screening and baseline evaluations up to 21 days prior to dosing. The cohorts may be enrolled sequentially. Subjects will be admitted to the clinic on Day 0.
All subjects will self-administer the all Day 1 doses of study drug under supervision of the clinic staff. In the pre-study cohort, subjects will be administered a single dose of 1600 mg. In Cohort 1, doses will be administered two times per day before the morning and evening meals with no less than 8 and no more than 10 hours between doses. Immediately after administration, subjects will ingest 6 ounces of tap or bottled water. Solid food and drinks, other than water should be restricted to 2 hours before and 1 hour after dosing. In Cohort 2 doses will be administered three times per day before meals, with no less than 4 and no more than 6 hours between doses. Immediately after administration, subjects will ingest 6 ounces of tap or bottled water. Solid food and drinks, other than water should be restricted to 2 hours before and 1 hour after dosing. Dosing will continue for an additional 4 days on an outpatient basis with the last study dose to be administered at the clinic on Day 5 (only morning dose is given on Day 5).
For the pre-study cohort, subjects will be administered a single dose of 1600 mg before breakfast. PK and PD sampling will be performed 30 minutes prior to dosing, and 0.5, 1, 2 and 4 hours later. Subjects will be evaluated for any untoward signs or symptoms and will be discharged. For cohorts 1 and 2, on Days 1, 2,and 5, pharmacokinetic (PK) and pharmacodynamics (PD) sampling will be performed 30 minutes prior to the first dose, and 0.5, 1, 2, and 4 hours after the first dose at all visits for BID and TID (with an additional PK draw on Day 1 at 0.5, 1, 2, and 4 after the second dose of TID subjects only). Urine for PK/PD will be collected pre-dose on Day 1, Day 2, and Day 5. At all visits (on Days 1, 2,and at the final dose on Day5), samples will be collected for chemistry, CBC, INR, PT, PTT, cholesterol, LDL, and HDL, and vitamin K level. Blood samples for PK/PD will be collected 30 minutes prior to the last dose (AM) on Day 5 and also at 0.5, 1, 2, and 4 hours after dosing. Lab samples (chemistry, etc.), as above will also be drawn at the time of the first PK/PD draw on Day 5.
A phone interview will be conducted no fewer than 25 days and no more than 35 days after the last dose on Day 5 to collect information on concomitant medications and adverse events (AEs).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: BPM31510 Oral Nanosuspension 4%In Cohort 1, doses of BPM31510 Oral Nanosuspension 4% will be administered two times per day before the morning and evening meals with no less than 8 and no more than 10 hours between doses. Immediately after administration, subjects will ingest 6 ounces of tap or bottled water. Solid food and drinks, other than water should be restricted to 2 hours before and 1 hour after dosing. |
| Cohort 2 | Active comparator | Drug: BPM31510 Oral Nanosuspension 4%In Cohort 2 doses BPM31510 Oral Nanosuspension 4% will be administered three times per day before meals, with no less than 4 and no more than 6 hours between doses. Immediately after administration, subjects will ingest 6 ounces of tap or bottled water. Solid food and drinks, other than water should be restricted to 2 hours before and 1 hour after dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 1. Men and women, age >18 years
- Body mass index (BMI)≥19 and ≤30
- Good health conditions or without significant illness, by judgment of a legally qualified professional, according to the following evaluations: medical history, physical examination, vital signs, electrocardiogram (ECG), and screening or baseline hematology and clinical chemistry measures.
- Subjects of child bearing potential must agree to use one of the accepted methods of contraception (listed below) during the trial (including the screening period prior to receiving trial medication), at least until return of menstruation after stopping the trial medication.
- The following subjects are not required to use contraception:
Key exclusion criteria (20 listed)
- Pregnant or lactating female subjects.
- Known hypersensitivity to the study drug (Coenzyme Q10) or to compounds chemically related.
- History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes with the drug's absorption, distribution, excretion or metabolism.
- History of hepatic, renal, pulmonary, gastrointestinal, epileptic, hematologic or psychiatric illness.
- Hypotension or hypertension of any etiologic that needs pharmacologic treatment.
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 |
|---|---|---|
| BPM31510 Oral Nanosuspension 4%Also: Coenzyme Q10, CoQ10, ubidecarenoneOral nanosuspension formulation of BPM31510 (ubidecarenone, USP) | Drug | Cohort 1, Cohort 2 |
Primary outcome
Cmax
Time frame: Days 1, 2, 8, and 15; baseline pre-dosing concentrations
PK parameters maximum plasma concentration (Cmax) and area under the plasma concentration curve from 0 to 4 hours (AUC0-4) on Days 1, 2, 8, and 15; baseline pre-dosing concentrations.
2 secondary outcomes
Blood sample analysis as a measure of safety and tolerability
Time frame: Days 1, 2, 8, and 15; baseline pre-dosing concentrations
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 30 to 45 days after the end of dosing
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 22 Dec 2016.
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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.
Magdy Shenouda, MD principal investigator
Clinilabs, 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 BPM31510 Oral Nanosuspension 4% in people with Healthy, run by BPGbio 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 17 inclusion and 20 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 22 Dec 2016. 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?
Cmax (time frame: Days 1, 2, 8, and 15; baseline pre-dosing concentrations). 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 22 Dec 2016.