Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers

NCT01444677 | Completed Phase 1 DMC

• 1 other identifier: MB12066_002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Syndrome; Obesity

Keywords

Safety; Tolerability; Pharmacokinetic

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events (single dose)

  Adverse events

  Single dose: from day-1 to day8-10

• Number of Patients with with Adverse Events (Multiple Dose)

  Adverse Events

  Multiple dose: from day-1 to day15-17

Secondary Outcomes (2)

• Composite of Pharmacokinetic Evaluation (single dose)

  between 0 (pre-dose) and 72 hours after a single oral dose.

• Composite of Pharmacokinetic Evaluation (multiple dose)

  between 0 (pre-dose) and 24 hours and between 7day and 11 day after a multiple oral dose.

Study Arms (5)

MB12066 300mg

EXPERIMENTAL

single dose

Drug: MB12066

MB12066 400mg

ACTIVE COMPARATOR

single dose

Drug: MB12066

MB12066 100mg

ACTIVE COMPARATOR

multiple dose

Drug: MB12066

MB12066 200mg

ACTIVE COMPARATOR

multiple dose

Drug: MB12066

Placebo

PLACEBO COMPARATOR

Placebo 300mg(single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose)

Drug: Placebo

Interventions

MB12066 DRUG

MB12066 300mg

Also known as: beta-lapachone

MB12066 300mg

Placebo DRUG

Placebo 300mg (single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose)

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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 %
• 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

Sponsors & Collaborators

• Yungjin Pharm. Co., Ltd.: lead
• KT&G Corporation: collaborator

Study Sites (1)

Clinical Research Institute of Seoul National University Hospital

Seoul, Daehang-ro, Jongno-Gu, 110-774, South Korea

Location

MeSH Terms

Conditions

Metabolic Syndrome; Obesity

Interventions

beta-lapachone

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyung-Sang Yu, Professor

  Clinical Research Institute of Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: October 3, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

KR (1)