NCT02529241

An Open-label, Single Dose, Parallel Design, Phase 1 Clinical Study of LCB01-0371

An Open-label, Single Dose, Parallel Design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral Dosage Form of LCB01-0371 in Healthy Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: LigaChem Biosciences, Inc. · Industry
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To investigate pharmacokinetics, safety and tolerability of LCB01-0371, LCB01-0371-B after a single oral dose in healthy male subjects. To investigate safety, tolerability of LCB01-0371 after a single oral dose in healthy male subjects.

Detailed description

An Open-label, Single dose, Parallel design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral dosage form of LCB01-0371 in Healthy Male Volunteers

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Group 1:LCB01-0371	1. Period:LCB01-0371 Tablet 400 mg 2. Period: LCB01-0371 Tablet 400 mg
DRUG	Group 2:LCB01-0371	1. Period:LCB01-0371 Tablet 800 mg 2. Period: LCB01-0371 Tablet 1200 mg

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-08-20
• Last updated: 2016-04-08

Locations

1 site across 1 country: South Korea