NCT01444677

Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• 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 or multiple oral dose and to investigate the pharmacokinetic characteristics of MB12066 after a single or multiple 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(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

Conditions

• Metabolic Syndrome
• Obesity

Interventions

Type	Name	Description
DRUG	MB12066	MB12066 300mg
DRUG	MB12066	MB12066 400mg
DRUG	MB12066	MB12066 100mg
DRUG	MB12066	MB12066 200mg
DRUG	Placebo	Placebo 300mg (single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose)

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-10-03
• Last updated: 2017-12-21

Locations

1 site across 1 country: South Korea