Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
KT&G Corporation
Information provided by (Responsible Party):
KT&G Life Sciences Corp
ClinicalTrials.gov Identifier:
NCT01444677
First received: September 21, 2011
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome
Obesity
Drug: MB12066
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Screening
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

Resource links provided by NLM:


Further study details as provided by KT&G Life Sciences Corp:

Primary Outcome Measures:
  • Number of participants with adverse events (single dose) [ Time Frame: Single dose: from day-1 to day8-10 ] [ Designated as safety issue: Yes ]
    Adverse events

  • Number of Patients with with Adverse Events (Multiple Dose) [ Time Frame: Multiple dose: from day-1 to day15-17 ] [ Designated as safety issue: Yes ]
    Adverse Events


Secondary Outcome Measures:
  • Composite of Pharmacokinetic Evaluation (single dose) [ Time Frame: between 0 (pre-dose) and 72 hours after a single oral dose. ] [ Designated as safety issue: No ]

    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


  • 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. ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 40
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MB12066 300mg
single dose
Drug: MB12066
MB12066 300mg
Other Name: beta-lapachone
Active Comparator: MB12066 400mg
single dose
Drug: MB12066
MB12066 400mg
Other Name: beta-lapachone
Active Comparator: MB12066 100mg
multiple dose
Drug: MB12066
MB12066 100mg
Other Name: beta-lapachone
Active Comparator: MB12066 200mg
multiple dose
Drug: MB12066
MB12066 200mg
Other Name: beta-lapachone
Placebo Comparator: Placebo
Placebo 300mg(single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose)
Drug: Placebo
Placebo 300mg (single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple 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
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Healthy Korean male volunteers, age ranged 20 to 45 years (both inclusive)
  3. 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
  4. 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:

  1. A subject with history of allergies including drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
  2. 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
  3. 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
  4. A subject whose hemoglobin(Hb) level < 12 g/dL
  5. A subject with fasting plasma glucose (FPG) level ≤ 70 mg/dL or ≥ 126 mg/dL
  6. A subject with HbA1c level ≥ 7.0 %
  7. 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
  8. A subject with history of drug abuse or positive urine drug screening test
  9. 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.)
  10. A subject who has participated in any other clinical trial either for investigational or marketed drugs within 8 weeks before the study drug administration
  11. A subject who has donated or had loss of ≥ 400 mL of blood within 8 weeks prior to start of administration of study drug
  12. A subject who consumes more than 21 units of alcohol per week or unable to stop drinking throughout the study period.
  13. A smoker (except for whom quitted smoking prior to the drug administration for at least 3 months)
  14. A subject who heavily takes caffeine or caffeine-containing products, grapefruit, grapefruit juice, grapefruit-containing products
  15. A subject with unusual dietary habit
  16. A subject who was previously assigned to treatment during this study
  17. The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444677

Locations
Korea, Republic of
Clinical Research Institute of Seoul National University Hospital
Seoul, Daehang-ro, Jongno-Gu, Korea, Republic of, 110-774
Sponsors and Collaborators
KT&G Life Sciences Corp
KT&G Corporation
Investigators
Principal Investigator: Kyung-Sang Yu, Professor Clinical Research Institute of Seoul National University Hospital
  More Information

No publications provided

Responsible Party: KT&G Life Sciences Corp
ClinicalTrials.gov Identifier: NCT01444677     History of Changes
Other Study ID Numbers: MB12066_002
Study First Received: September 21, 2011
Last Updated: July 16, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by KT&G Life Sciences Corp:
Safety
Tolerability
Pharmacokinetic

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Beta-lapachone
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on October 19, 2014