Overview

Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
KT&G Life Sciences Corp
Yungjin Pharm. Co., Ltd.
Collaborator:
KT&G Corporation
Treatments:
Beta-lapachone
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 mmol/L

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.