Overview

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

Status:
Completed
Trial end date:
2023-10-19
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Forest Hills Lab
Collaborator:
Liberyx
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.