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

• ClinicalTrials.gov Identifier: NCT05938452
• Recruitment Status: Completed
• First Posted: July 10, 2023
• Last Update Posted: January 11, 2024
• Sponsor: Forest Hills Lab
• Collaborator: Liberyx
• Information provided by (Responsible Party): Forest Hills Lab

Tracking Information

• First Submitted Date: June 15, 2023
• First Posted Date: July 10, 2023
• Last Update Posted Date: January 11, 2024
• Actual Study Start Date: December 12, 2022
• Actual Primary Completion Date: October 19, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 3, 2023)

• 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).
• Treatment-Emergent Adverse Events Withdrawals [ Time Frame: 7 days ]
  Incidence of TEAEs leading to withdrawal of study drug or study discontinuation.
• Laboratory Results [ Time Frame: 7 days ]
  Change from baseline in clinical laboratory results.
• Physical Results [ Time Frame: 7 days ]
  Change from baseline in physical examination results
• Vital Signs [ Time Frame: 7 days ]
  Change from baseline in vital signs.
• Electrocardiogram [ Time Frame: 7 days ]
  Change from baseline in 12-lead electrocardiogram (ECG).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Tolerability of Glyceryl Tribenzoate (GTB) Capsules in Healthy Subjects
• 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
• 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).
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Neurological Disorder

Intervention

Drug: Glyceryl Tribenzoate

Oral Solution

Study Arms

• Experimental: Active
  Active Comparator
  Intervention: Drug: Glyceryl Tribenzoate
• Placebo Comparator: Placebo
  Placebo Comparator
  Intervention: Drug: Glyceryl Tribenzoate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 3, 2023): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 19, 2023
• Actual Primary Completion Date: October 19, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05938452
• Other Study ID Numbers: FHL-101-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Forest Hills Lab
• Original Responsible Party: Same as current
• Current Study Sponsor: Forest Hills Lab
• Original Study Sponsor: Same as current
• Collaborators: Liberyx
• Investigators: Not Provided
• PRS Account: Forest Hills Lab
• Verification Date: June 2023