Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Male Volunteers

Metabolic Syndrome Clinical Trial

Official title:

A Phase I Clinical Trial to Evaluate the Pharmacokinetics and Safety of MB12066 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338856
• Other study ID #: MB12066_003
• Status: Completed
• Phase: Phase 1
• First received: January 11, 2015
• Last updated: December 19, 2017
• Start date: January 2015
• Est. completion date: February 2015

Study information

• Verified date: December 2017
• Source: Yungjin Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and tolerability of MB12066 after multiple dose and to investigate the pharmacokinetic characteristics of MB12066 after multiple dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

• 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 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

• 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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Drug:
• MB12066 200mg
100mg bid (multiple dose, day 8)
• Placebo
100mg bid (multiple dose, day 8)

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu	Dongduck-ro, Jung-gu

Sponsors (1)

Lead Sponsor	Collaborator
Yungjin Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of reported adverse events		from day 1 to day 14-18
Secondary	Composite of Pharmacokinetic parameters	day 1 : pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24h day 5 : pre-dose(morning) day 8 : pre-dose(0h), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 36, 48, 60h	day 1, day 5, day 8