IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-07-31

Brief Summary

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Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary

• To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LCB01-0371 200mg

LCB01-0371 IV 200 mg

Group Type EXPERIMENTAL

LCB01-0371

Intervention Type DRUG

Cohort1 \& 3: Placebo-controlled, Single ascending dose administration

LCB01-0371 400mg

LCB01-0371 IV 400 mg

Group Type EXPERIMENTAL

LCB01-0371

Intervention Type DRUG

Cohort1 \& 3: Placebo-controlled, Single ascending dose administration

LCB01-0371 400mg

Intervention Type DRUG

Cohort 2: Crossover designed administration

LCB01-0371 800mg

LCB01-0371 IV 800 mg

Group Type EXPERIMENTAL

LCB01-0371

Intervention Type DRUG

Cohort1 \& 3: Placebo-controlled, Single ascending dose administration

Interventions

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LCB01-0371

Cohort1 \& 3: Placebo-controlled, Single ascending dose administration

Intervention Type DRUG

LCB01-0371 400mg

Cohort 2: Crossover designed administration

Intervention Type DRUG

Other Intervention Names

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LCB01-0371 or placebo LCB01-0371 400mg 2 tablet

Eligibility Criteria

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Inclusion Criteria

1. Healthy Male between 19 and 39 years of age at the time of screening
2. Subjects with body mass index (BMI) between 19 and 27 at the time of screening
3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 28 days of study completion
4. 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) which is affect to absorption OR surgical history except appendectomy, herniotomy
2. History of allergy, cardiovascular, peripheral vascular, skin, mucous membrane, eyes, otorhinolaryngologic, respiratory, musculoskeletal, infectious disease, gastroenterologic, liver, billiary, endocrinologic, kidney, genitourinary, neuropsychiatric, hemato-oncologic problem(s) or fracture etc.

Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes