Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers
Primary Purpose
Metabolic Syndrome, Obesity
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MB12066
Sponsored by
About this trial
This is an interventional screening trial for Metabolic Syndrome focused on measuring Safety, Tolerability, Pharmacokinetic
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
MB12066 10mg
MB12066 30mg
MB12066 100mg
MB12066 150mg
MB12066 200mg
placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01285388
First Posted
July 4, 2010
Last Updated
June 25, 2018
Sponsor
Yungjin Pharm. Co., Ltd.
Collaborators
KT&G Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01285388
Brief Title
Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yungjin Pharm. Co., Ltd.
Collaborators
KT&G Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
Keywords
Safety, Tolerability, Pharmacokinetic
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MB12066 10mg
Arm Type
Experimental
Arm Title
MB12066 30mg
Arm Type
Active Comparator
Arm Title
MB12066 100mg
Arm Type
Active Comparator
Arm Title
MB12066 150mg
Arm Type
Active Comparator
Arm Title
MB12066 200mg
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MB12066
Other Intervention Name(s)
beta-lapachone
Intervention Description
MB12066 10mg, 100mg/tab. once oral dose MB12066 10, 30, 100, 150, 200mg
Primary Outcome Measure Information:
Title
Safety/ Tolerability evaluation
Description
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
Time Frame
from day-1 to day8-10
Secondary Outcome Measure Information:
Title
Pharmacokinetic Evaluation
Description
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
Time Frame
between 0 (pre-dose) and 96 hours after a single oral dose.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Sang Yu, Professor
Organizational Affiliation
Clinical Research Institute of Seoul National University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers
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