Safety, Tolerability and Pharmacokinetic Study of MB12066 in Healthy Volunteers

Obesity Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

• NCT number: NCT01444677
• Study type: Interventional
• Source: Yungjin Pharm. Co., Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: April 2011
• Completion date: April 2012