Metabolic SyndromePhase 1NCT01444677
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. at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the safety and tolerability of MB12066 after a single or multiple oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a single or multiple 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Apr 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 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 %
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Research Institute of Seoul National University Hospital
Seoul, Daehang-ro, Jongno-Gu, 110-774
About this study
Official title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single or Multiple 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 or multiple oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a single or multiple 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(single)
- 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, 0.5, 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
- Pharmacokinetic Evaluation(multiple)
- Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted after a single oral dose and Steady state.
- Blood sampling time Day 1 pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, Day3-6 Pre-dose, Day7 Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h post-dose
- Urine collection time Day 1 Pre-dose, 0h - 6h, 6h - 12h, 12h - 24h, Day 7 Pre-dose, 0h - 6h, 6h - 12h, 12h - 24h
- Evaluation parameters Cmax,ss, Cmin,ss, Cav,ss, AUCτ, Tmax,ss, t1/2, PTF(peak to trough fluctuation ratio), fe, CLss/F, CLR
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- MB12066, Placebo
- 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 300mg
MB12066Drug
Also called beta-lapachone
MB12066 400mg
MB12066Drug
Also called beta-lapachone
MB12066 100mg
MB12066Drug
Also called beta-lapachone
MB12066 200mg
PlaceboDrug
Placebo 300mg (single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose)
| Study group | Role | What they receive |
|---|---|---|
| MB12066 300mg | Experimental | single dose Receives: Drug: MB12066 |
| MB12066 400mg | Active comparator | single dose Receives: Drug: MB12066 |
| MB12066 100mg | Active comparator | multiple dose Receives: Drug: MB12066 |
| MB12066 200mg | Active comparator | multiple dose Receives: Drug: MB12066 |
| Placebo | Placebo comparator | Placebo 300mg(single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (single dose)
Adverse events
Measured: Single dose: from day-1 to day8-10
Number of Patients with with Adverse Events (Multiple Dose)
Adverse Events
Measured: Multiple dose: from day-1 to day15-17
Secondary outcomes (2)
Composite of Pharmacokinetic Evaluation (single dose)
Single oral dose
- Blood sampling time pre-dose, 0.5h, 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 Cmax,ss, Cmin,ss, Cav,ss, AUCτ, Tmax,ss, t1/2, PTF(peak to trough fluctuation ratio), fe, CLss/F, CLR
Measured: between 0 (pre-dose) and 72 hours after a single oral dose.
Composite of Pharmacokinetic Evaluation (multiple dose)
Multiple oral dose
- Blood sampling time Day 1 pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h post-dose Day 3-6 pre-dose Day 7 pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h post-dose
- Urine collection time Day 1 0h - 6h, 6h - 12h, 12h - 24h Day 7 0h - 6h, 6h - 12h, 12h - 24h
Evaluation parameters Cmax,ss, Cmin,ss, Cav,ss, AUCτ, Tmax,ss, t1/2, PTF(peak to trough fluctuation ratio), fe, CLss/F, CLR
Measured: between 0 (pre-dose) and 24 hours and between 7day and 11 day after a multiple oral dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2012
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
- 40 participants (estimated)
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
- NCT01444677
- Sponsor's protocol ID
- MB12066_002
- Status last verified
- Dec 2017
- First submitted
- 21 Sep 2011
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Block-randomized, Double-blind, Placebo-controlled, Single or Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of MB12066 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01444677
- Acronym / sponsor ID
- MB12066_002
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- Safety, Tolerability, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yungjin Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KT&G Corporation
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Oct 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 or multiple oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a single or multiple 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(single)
- 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, 0.5, 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
- Pharmacokinetic Evaluation(multiple)
- Serial blood samples and urine collections for pharmacokinetic evaluations will be conducted after a single oral dose and Steady state.
- Blood sampling time Day 1 pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, Day3-6 Pre-dose, Day7 Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h post-dose
- Urine collection time Day 1 Pre-dose, 0h - 6h, 6h - 12h, 12h - 24h, Day 7 Pre-dose, 0h - 6h, 6h - 12h, 12h - 24h
- Evaluation parameters Cmax,ss, Cmin,ss, Cav,ss, AUCτ, Tmax,ss, t1/2, PTF(peak to trough fluctuation ratio), fe, CLss/F, CLR
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MB12066 300mg | Experimental | Drug: MB12066single dose |
| MB12066 400mg | Active comparator | Drug: MB12066single dose |
| MB12066 100mg | Active comparator | Drug: MB12066multiple dose |
| MB12066 200mg | Active comparator | Drug: MB12066multiple dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 300mg(single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose) |
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 300mg | Drug | MB12066 300mg |
| MB12066Also: beta-lapachoneMB12066 400mg | Drug | MB12066 400mg |
| MB12066Also: beta-lapachoneMB12066 100mg | Drug | MB12066 100mg |
| MB12066Also: beta-lapachoneMB12066 200mg | Drug | MB12066 200mg |
| PlaceboPlacebo 300mg (single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose) | Drug | Placebo |
Primary outcome
Number of participants with adverse events (single dose)
Time frame: Single dose: from day-1 to day8-10
Adverse events
Number of Patients with with Adverse Events (Multiple Dose)
Time frame: Multiple dose: from day-1 to day15-17
Adverse Events
2 secondary outcomes
Composite of Pharmacokinetic Evaluation (single dose)
Time frame: between 0 (pre-dose) and 72 hours after a single oral dose.
Composite of Pharmacokinetic Evaluation (multiple dose)
Time frame: between 0 (pre-dose) and 24 hours and between 7day and 11 day after a multiple 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 21 Dec 2017.
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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
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 MB12066 in people with Metabolic Syndrome and Obesity, run by Yungjin Pharm. Co., Ltd. at 1 site in South Korea.
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 21 Dec 2017. 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 South Korea. 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?
Number of participants with adverse events (single dose) (time frame: Single dose: from day-1 to day8-10). The study lists 2 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 21 Dec 2017.