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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02529241
• Other study ID #: LCB01-0371-15-1-01
• Status: Terminated
• Phase: Phase 1
• First received: August 12, 2015
• Last updated: April 7, 2016
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: LegoChem Biosciences, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Healthy male between 20 and 40 years of age at the time of screening

2. Agree to continue to use a medically reliable dual contraception and not to donate sperm in this protocol for the duration of the study and for 28 days after last dose of investigational product

3. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria:

1. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)

2. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics

3. History of clinically significant disease such as allergic or anaphylactic reaction to drug, cardiovascular, peripheral vascular system, skin, mucous membrane, eye, otorhinolaryngologic system, respiratory, musculoskeletal, infection disease, Gastrointestinal system , liver, biliary system, endocrine, kidney, urogenital system, nervous system, psychiatric system, blood dyscrasia, tumor, fracture, problem(s)

4. blood donation and transfusion within 60 days prior to screening visit

5. Treatment with an other investigational product or Participation in other bioequivalence test within 90 days prior to screening visit

6. Use medication which expected to influence in this study within 30 days prior to screening visit

7. smokers over 10 cigarettes per day within 30 days prior to screening visit or unable to stop smoking in this protocol for the duration of the study from first dose of investigational product

8. drinkers over 3 glasses alcohol drink per week within 30 days prior to screening visit or unable to stop drinking in this protocol for the duration of the study from first dose of investigational product

9. positive result at urine drug screening test or urine nicotine test at screening visit

10. positive result at serum test(hepatitis B, hepatitis C, HIV, syphilis) at screening visit

11. corrected QT interval >450 msec or significant abnormalities on screening ECG

12. other: Patients considered unable perform for the study by the investigator concerning

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Group 1:LCB01-0371
Period:LCB01-0371 Tablet 400 mg Period: LCB01-0371 Tablet 400 mg
• Group 2:LCB01-0371
Period:LCB01-0371 Tablet 800 mg Period: LCB01-0371 Tablet 1200 mg

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LegoChem Biosciences, Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Peak Plasma Concentration (Cmax)		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours	No
Primary	Pharmacokinetics: time to maximum concentration (Tmax)		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours	No
Primary	Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)		0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours	No
Secondary	Number of Adverse Event		participants will be followed after hospital stay, an expected average of 16 weeks	Yes