Metabolic SyndromePhase 1NCT01285388
Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers
A Phase 1 study testing MB12066 in people with Metabolic Syndrome and Obesity, run by Yungjin Pharm. Co., Ltd..
Trial summary
The purpose of this study is to investigate the safety and tolerability of MB12066 after a single oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a single oral dose. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- MB12066
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Jan 2011
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures
- Healthy Korean male volunteers, age ranged 20 to 45 years (both inclusive)
- A subject with body weight between 60 kg (inclusive) and 90 kg (exclusive) and body mass index (BMI) between 18.5 (inclusive) and 25 (exclusive). ☞ BMI (kg/m2) = weight (kg) / {height (m)}2
- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (unless the investigator considers the deviation to be irrelevant for the purpose of the study)
Who cannot join
- A subject with history of allergies including drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
- A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
- A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- A subject whose hemoglobin(Hb) level < 12 g/dL
- A subject with fasting plasma glucose (FPG) level ≤ 70 mg/dL or ≥ 126 mg/dL
- A subject with HbA1c level ≥ 7.0 mmol/L
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- A subject whose systolic blood pressure (SBP) ≤ 90 mmHg or ≥ 140 mmHg, diastolic blood pressure (DBP) ≤ 40 mmHg or ≥ 90 mmHg or pulse rate (PR) ≥ 100 /min after at least 5 min sitting
- A subject with history of drug abuse or positive urine drug screening test
- A subject who has taken any prescribed medication or herbal compounds within 14 days prior to the study drug administration. In addition, a subject who has taken any over-the-counter drug or vitamin supplements within 7 days prior to the study drug administration (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied.)
- A subject who has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration
- A subject who has donated or had loss of ≥ 400 mL of blood within 8 weeks prior to start of administration of study drug
- A subject who consumes more than 21 units of alcohol per week or unable to stop drinking throughout the study period.
- A smoker (except for whom quitted smoking prior to the drug administration for at least 3 months)
- A subject who heavily takes caffeine or caffeine-containing products, grapefruit, grapefruit juice, grapefruit-containing products
- A subject with unusual dietary habit
- A subject who was previously assigned to treatment during this study
- The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons.
About this study
Official title: A Dose Double-blind,Placebo-controlled,Single Dosing,Dose-escalation Clinical Trial to Investigate the Safety,Tolerability and Pharmacokinetic Characteristics of MB12066 in Healthy Male Subjects
The purpose of this study is to investigate the safety and tolerability of MB12066 after a single oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a single oral dose.
Read the detailed description
- Safety/ Tolerability evaluation -Adverse events, Physical examinations, Vital signs, ECG (including continuous ECG monitoring), Laboratory tests (including hematology, chemistry, coagulation, PBS, NAD(P)+/NAD(P)H ratio, urinalysis), CIC
- Pharmacokinetic Evaluation
- Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted between 0 (pre-dose) and 96 hours after a single oral dose.
- Blood sampling time pre-dose, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h post-dose
- Urine collection time 0h - 6h, 6h - 12h, 12h - 24h, 24h - 48h, 48h - 72h
- Evaluation parameters AUClast, AUCinf, Cmax, Tmax, t1/2, Vd/F, CL/F, Ae, fe, CLR
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- MB12066
- Keywords
- Safety, Tolerability, Pharmacokinetic
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB12066Drug
Also called beta-lapachone
MB12066 10mg, 100mg/tab. once oral dose MB12066 10, 30, 100, 150, 200mg
| Study group | Role | What they receive |
|---|---|---|
| MB12066 10mg | Experimental | Not described Receives: Drug: MB12066 |
| MB12066 30mg | Active comparator | Not described Receives: Drug: MB12066 |
| MB12066 100mg | Active comparator | Not described Receives: Drug: MB12066 |
| MB12066 150mg | Active comparator | Not described Receives: Drug: MB12066 |
| MB12066 200mg | Active comparator | Not described Receives: Drug: MB12066 |
| placebo | Placebo comparator | Not described Receives: Drug: MB12066 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/ Tolerability evaluation
Adverse events, Physical examinations, Vital signs, ECG (including continuous ECG monitoring), Laboratory tests (including hematology, chemistry, coagulation, PBS, NAD(P)+/NAD(P)H ratio, urinalysis), CIC
Measured: from day-1 to day8-10
Secondary outcomes (1)
Pharmacokinetic Evaluation
- Blood sampling time pre-dose, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h post-dose
- Urine collection time 0h - 6h, 6h - 12h, 12h - 24h, 24h - 48h, 48h - 72h
- Evaluation parameters AUClast, AUCinf, Cmax, Tmax, t1/2, Vd/F, CL/F, Ae, fe, CLR
Measured: between 0 (pre-dose) and 96 hours after a single oral dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yungjin Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KT&G Corporation
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, Professor, Principal investigator, Clinical Research Institute of Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285388
- Sponsor's protocol ID
- MB12066_001
- Status last verified
- Jun 2018
- First submitted
- 4 Jul 2010
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Double-blind,Placebo-controlled,Single Dosing,Dose-escalation Clinical Trial to Investigate the Safety,Tolerability and Pharmacokinetic Characteristics of MB12066 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01285388
- Acronym / sponsor ID
- MB12066_001
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- Safety, Tolerability, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yungjin Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KT&G Corporation
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Jan 2011 (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 investigate the safety and tolerability of MB12066 after a single oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a single oral dose.
Detailed description
- Safety/ Tolerability evaluation -Adverse events, Physical examinations, Vital signs, ECG (including continuous ECG monitoring), Laboratory tests (including hematology, chemistry, coagulation, PBS, NAD(P)+/NAD(P)H ratio, urinalysis), CIC
- Pharmacokinetic Evaluation
- Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted between 0 (pre-dose) and 96 hours after a single oral dose.
- Blood sampling time pre-dose, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h post-dose
- Urine collection time 0h - 6h, 6h - 12h, 12h - 24h, 24h - 48h, 48h - 72h
- Evaluation parameters AUClast, AUCinf, Cmax, Tmax, t1/2, Vd/F, CL/F, Ae, fe, CLR
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MB12066 10mg | Experimental | Drug: MB12066 |
| MB12066 30mg | Active comparator | Drug: MB12066 |
| MB12066 100mg | Active comparator | Drug: MB12066 |
| MB12066 150mg | Active comparator | Drug: MB12066 |
| MB12066 200mg | Active comparator | Drug: MB12066 |
| placebo | Placebo comparator | Drug: MB12066 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures
- Healthy Korean male volunteers, age ranged 20 to 45 years (both inclusive)
- A subject with body weight between 60 kg (inclusive) and 90 kg (exclusive) and body mass index (BMI) between 18.5 (inclusive) and 25 (exclusive). ☞ BMI (kg/m2) = weight (kg) / {height (m)}2
- Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests (unless the investigator considers the deviation to be irrelevant for the purpose of the study)
Key exclusion criteria (17 listed)
- A subject with history of allergies including drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
- A subject with clinical evidence or history of hepatic (including carrier of hepatitis virus), renal, respiratory, endocrine, neurologic, immunologic, hematologic, oncologic, psychiatric, or cardiovascular disease
- A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug
- A subject whose hemoglobin(Hb) level < 12 g/dL
- A subject with fasting plasma glucose (FPG) level ≤ 70 mg/dL or ≥ 126 mg/dL
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 |
|---|---|---|
| MB12066Also: beta-lapachoneMB12066 10mg, 100mg/tab. once oral dose MB12066 10, 30, 100, 150, 200mg | Drug | MB12066 100mg, MB12066 10mg, MB12066 150mg, MB12066 200mg, MB12066 30mg, placebo |
Primary outcome
Safety/ Tolerability evaluation
Time frame: from day-1 to day8-10
Adverse events, Physical examinations, Vital signs, ECG (including continuous ECG monitoring), Laboratory tests (including hematology, chemistry, coagulation, PBS, NAD(P)+/NAD(P)H ratio, urinalysis), CIC
1 secondary outcome
Pharmacokinetic Evaluation
Time frame: between 0 (pre-dose) and 96 hours after a single oral 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 27 Jun 2018.
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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.
Kyung-Sang Yu, Professor principal investigator
Clinical Research Institute of Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MB12066 in people with Metabolic Syndrome and Obesity, run by Yungjin Pharm. Co., Ltd..
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 4 inclusion and 17 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 27 Jun 2018. 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. 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?
Safety/ Tolerability evaluation (time frame: from day-1 to day8-10). 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 27 Jun 2018.