The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Tolerability of Glyceryl Tribenzoate (GTB) Capsules in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05938452
Recruitment Status : Completed
First Posted : July 10, 2023
Last Update Posted : January 11, 2024
Sponsor:
Collaborator:
Liberyx
Information provided by (Responsible Party):
Forest Hills Lab

Brief Summary:
This study is designed to assess the safety and PK/PD of GTB and Benzoic Acid (Benzoate) using a single ascending dose (SAD) study (under fasting conditions).

Condition or disease Intervention/treatment Phase
Neurological Disorder Drug: Glyceryl Tribenzoate Phase 1

Detailed Description:
This study is designed to assess the safety and PK/PD of GTB and Benzoic Acid (Benzoate) using a single ascending dose (SAD) study (under fasting conditions). After a wash out period, a cohort under fed conditions (ingestion of a high-fat morning meal) will be evaluated. Following the SAD, the multiple ascending dose phase will take place with two different cohorts. A battery of labs, hematology, physical examinations including vital signs, and ECGs will be monitored throughout the study for assessment of the study drug (GTB) compared with placebo. The clinical and laboratory data (excluding PK/PD data) of each cohort will be evaluated by a Data Monitoring Committee (DMC) to allow escalation to the next dose level during the SAD and MAD portions of the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Single-Dose Escalation Study Followed by a Multiple-Dose Escalating Study of Glyceryl Tribenzoate (GTB) Capsules in Healthy Subjects
Actual Study Start Date : December 12, 2022
Actual Primary Completion Date : October 19, 2023
Actual Study Completion Date : October 19, 2023

Arm Intervention/treatment
Experimental: Active
Active Comparator
Drug: Glyceryl Tribenzoate
Oral Solution

Placebo Comparator: Placebo
Placebo Comparator
Drug: Glyceryl Tribenzoate
Oral Solution




Primary Outcome Measures :
  1. Treatment-Emergent Adverse Events [ Time Frame: 7 days ]

    Incidence of Treatment-Emergent Adverse Events (TEAEs) until 30 days after the last administration of the study medication.

    6. Change from baseline in 12-lead electrocardiogram (ECG).


  2. Treatment-Emergent Adverse Events Withdrawals [ Time Frame: 7 days ]
    Incidence of TEAEs leading to withdrawal of study drug or study discontinuation.

  3. Laboratory Results [ Time Frame: 7 days ]
    Change from baseline in clinical laboratory results.

  4. Physical Results [ Time Frame: 7 days ]
    Change from baseline in physical examination results

  5. Vital Signs [ Time Frame: 7 days ]
    Change from baseline in vital signs.

  6. Electrocardiogram [ Time Frame: 7 days ]
    Change from baseline in 12-lead electrocardiogram (ECG).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed informed consent prior to any study-related procedures.
  2. Male or female subjects 18 to 50 years of age inclusive.
  3. Subject's body mass index (BMI) is ≥ 18 kg/m2 and ≤ 30 kg/m2.
  4. Female subjects of childbearing potential must not be pregnant or lactating with a negative serum human chorionic gonadotropin (HCG) pregnancy test result at Screening, and negative urine pregnancy test on Day -1 (including Day -1 of Period 2 for SAD dosing participants i.e., fed cohort).
  5. Female subjects of childbearing potential must use an adequate method of contraception from Screening until 30 days after last dose of study medication. Acceptable methods of contraception are barrier methods (female condom, diaphragm, cervical cap, spermicide, or intrauterine device [IUD]), surgical sterility (self-reported: tubal ligation, hysterectomy, and/or bilateral oophorectomy), oral hormonal contraceptives, hormonal IUD, and/or postmenopausal status (defined as at least 1 year without menses as demonstrated by medical history or subject report).
  6. Male subjects must use an adequate method of contraception from Screening until 30 days after last dose of study medication. Acceptable methods of contraception are barrier methods (condom), surgical sterility (self-reported), must also refrain from donating sperm while on study medication and until 30 days after last dose of study medication.
  7. Subject is in good health as determined by vital signs, medical history, physical exam, ECG, and safety laboratory analyses at Screening and during the study.
  8. Subject is negative for SARS-CoV-2 virus at admission Day -1 and Day 1 (during the SAD, Fed portion of the study, and MAD).
  9. Subject does not have dysphagia and discomfort with swallowing tablets/capsules.

Exclusion Criteria:

  1. Subject has used an investigational product or device within 30 days prior to enrollment or during the study.
  2. Subject has used prescription or non-prescription drugs (including vitamins, minerals, and herbal/plant-derived preparations) within 2 weeks of enrollment (excluding hormonal IUD, oral hormonal contraceptives, hormone replacement therapy, and acetaminophen) unless deemed acceptable by the Investigator in consultation with the Sponsor.
  3. Subject has a positive drug and/or alcohol test at Screening and on Day -1 (including 4. Day -1 of Period 2 for SAD dosing participants, i.e., fed cohort).
  4. Subject has a history of drug or alcohol abuse within 2 years before Screening.
  5. Subject is unable to abstain from ingesting alcohol or smoking for 72 hours prior to dosing and throughout the study.
  6. Concurrent use of probenecid, penicillin or other ß-lactams, or other drugs which undergo active tubular secretion in the kidneys.
  7. The subject has a clinically significant history of endocrinologic, hematologic, hepatic, immunologic, metabolic, cardiovascular, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases or malignancy.
  8. Allergy to sodium benzoate.
  9. Has an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months or a suicide attempt in the past 3 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05938452


Locations
Layout table for location information
United States, New Jersey
TKL Research
Bloomfield, New Jersey, United States, 07003
Sponsors and Collaborators
Forest Hills Lab
Liberyx
Layout table for additonal information
Responsible Party: Forest Hills Lab
ClinicalTrials.gov Identifier: NCT05938452    
Other Study ID Numbers: FHL-101-001
First Posted: July 10, 2023    Key Record Dates
Last Update Posted: January 11, 2024
Last Verified: June 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Nervous System Diseases