IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers
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
1 other identifier
interventional
24
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Sep 2016
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2016
CompletedFirst Posted
Study publicly available on registry
August 30, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedApril 10, 2018
March 1, 2017
10 months
August 9, 2016
April 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
To assess Peak Plasma Concentration(Cmax) of LCB01-0371
through study completion per patient, an average of 8 days (+ - 1 D)
Study Arms (3)
LCB01-0371 200mg
EXPERIMENTALLCB01-0371 IV 200 mg
LCB01-0371 400mg
EXPERIMENTALLCB01-0371 IV 400 mg
LCB01-0371 800mg
EXPERIMENTALLCB01-0371 IV 800 mg
Interventions
Cohort1 \& 3: Placebo-controlled, Single ascending dose administration
Cohort 2: Crossover designed administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bae KS
Seoul, 05505, South Korea
Related Publications (1)
Cho YS, Lim HS, Han S, Yoon SK, Kim H, Cho YL, Nam HS, Bae KS. Single-dose Intravenous Safety, Tolerability, and Pharmacokinetics and Absolute Bioavailability of LCB01-0371. Clin Ther. 2019 Jan;41(1):92-106. doi: 10.1016/j.clinthera.2018.11.009. Epub 2018 Dec 15.
PMID: 30559004DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2016
First Posted
August 30, 2016
Study Start
September 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
April 10, 2018
Record last verified: 2017-03