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OpenTrials
Completed

NCT Number: NCT02882789

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

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

Completed

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Key information

Conditions

Healthy

Age range

19 year–39 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Bae KS

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Male between 19 and 39 years of age at the time of screening
  • Subjects with body mass index (BMI) between 19 and 27 at the time of screening
  • Agree to continue to use a medically reliable dual contraception and not to donate sperm until 28 days of study completion
  • Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion criteria

  • History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption OR surgical history except appendectomy, herniotomy
  • 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.

Treatment and study plan

LCB01-0371

Drug

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

Other names: LCB01-0371 or placebo

LCB01-0371 400mg

Drug

Cohort 2: Crossover designed administration

Other names: LCB01-0371 400mg 2 tablet

Primary outcomes

  1. To assess Peak Plasma Concentration(Cmax) of LCB01-0371

    Time frame: through study completion per patient, an average of 8 days (+ - 1 D)

Sponsors and collaborators

Lead sponsor

LigaChem Biosciences, Inc.

Industry

Registry information

Official study title

A Randomized, Single Blind, Single Dose, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous Dosage Form of LCB01-0371 in Healthy Male Volunteers

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 30, 2016
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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