NCT01285388

Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Yungjin Pharm. Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Metabolic Syndrome
• Obesity

Interventions

Type	Name	Description
DRUG	MB12066	MB12066 10mg, 100mg/tab. once oral dose MB12066 10, 30, 100, 150, 200mg

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2011-01-28
• Last updated: 2018-06-27