Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03492996
Other study ID # LCB01-0371-17-1-06
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received April 1, 2018
Last updated April 9, 2018
Start date September 1, 2018
Est. completion date December 20, 2018

Study information

Verified date March 2018
Source LegoChem Biosciences, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objectives of the study are:

• To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects


Description:

This is a single-center, open-label, non-randomized, one-sequence, one-period, single arm study in healthy male subjects. A total of 6 subjects will be enrolled in the study, and a minimum of 4 evaluable subjects are considered sufficient. An evaluable subject is defined as a subject who has provided whole blood, plasma, exhalation and excreta samples sufficient for evaluation of the primary objectives. Study subjects will be screened for eligibility to participate in the study within 28 days before dosing.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 4
Est. completion date December 20, 2018
Est. primary completion date October 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 46 Years
Eligibility Inclusion Criteria:

- 1) Healthy male adults aged 19 to 46 (inclusive) years, at the time of screening.

2) Body weight at least 55 kg and calculated Body Mass Index (BMI) ranging from 18.0 to 25.0 kg/m2, inclusive, at screening, or if outside the range, considered not clinically significant by the investigator BMI (kg/m2) = body weight (kg) / {height (m)}2

3) Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study

Exclusion Criteria:

- 1) Subjects who had a clinically significant disease or a past history of disease in their liver (including viral hepatitis), renal system, neurologic system, immune system, pulmonary system, endocrine system, cardiovascular system, hematologic system, oncology, or psychical disorder (mood disorder, obsessive compulsive disorder, etc.).

2) Subjects who had a past history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may have affected to absorption for the study drug.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose
To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
LegoChem Biosciences, Inc

Outcome

Type Measure Description Time frame Safety issue
Primary Assess the AME of LCB01-0371 To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects.
Blood, urine, feces, and expired air samples will be collected according to the following schedules
Blood: Plasma(20 points), Whole blood(2 points)
Urine : 11 points
Feces : 8 points
Expired air: 14points
an average of 8 days (+ - 1 D)
See also
  Status Clinical Trial Phase
Terminated NCT00001844 - Study of New Magnetic Resonance Methods
Completed NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Recruiting NCT03662100 - A Study of Two Formulations of LY3074828 in Healthy Participants Phase 1
Recruiting NCT02875301 - Investigating Gains in Neurocognition in an Intervention Trial of Exercise Phase 3
Recruiting NCT03670082 - Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State Phase 1
Recruiting NCT03656952 - A Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers Phase 1
Completed NCT03056846 - Probiotics on Stress-associated Gastrointestinal Function in University Students N/A
Completed NCT03203824 - The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals N/A
Recruiting NCT03114839 - Effect of Lactobacillus Casei Shirota on the Small Intestinal Microbiota (ROBIN) N/A
Completed NCT03259464 - This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated Phase 1
Completed NCT03224702 - First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers Phase 1
Completed NCT03309566 - Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir Phase 4
Completed NCT00527579 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FB Phase 1
Completed NCT00526916 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28 Phase 1
Completed NCT03373162 - Functional Effects of Botox on the Brain Using MRS and fMRI Phase 4
Active, not recruiting NCT02509494 - Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo During Implementation of Stages 1 and 2 Phase 3
Terminated NCT02555085 - Single Ascending Doses of BIIB063 in Healthy Volunteers Phase 1
Completed NCT03125018 - Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX) N/A
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT00004556 - The Effects of Dextroamphetamine on Brain Function