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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05391880




Registration number
NCT05391880
Ethics application status
Date submitted
12/05/2022
Date registered
26/05/2022
Date last updated
18/09/2023

Titles & IDs
Public title
Study of Orally Administered BEBT-503 in Healthy Subjects
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study of Orally Administered BEBT-503 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects
Secondary ID [1] 0 0
GBMT-503-P01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BEBT-503 20mg
Treatment: Drugs - BEBT-503 40mg
Treatment: Drugs - BEBT-503 80mg
Treatment: Drugs - BEBT-503 120mg
Treatment: Drugs - BEBT-503 180mg
Treatment: Drugs - placebo 20mg
Treatment: Drugs - placebo 40mg
Treatment: Drugs - placebo 80mg
Treatment: Drugs - placebo 120mg
Treatment: Drugs - placebo 180mg

Experimental: Drug:BEBT-503 - BEBT-503

Placebo comparator: Drug: Placebo - Placebo


Treatment: Drugs: BEBT-503 20mg
BEBT-503 capsule

Treatment: Drugs: BEBT-503 40mg
BEBT-503 capsule

Treatment: Drugs: BEBT-503 80mg
BEBT-503 capsule

Treatment: Drugs: BEBT-503 120mg
BEBT-503 capsule

Treatment: Drugs: BEBT-503 180mg
BEBT-503 capsule

Treatment: Drugs: placebo 20mg
placebo capsule

Treatment: Drugs: placebo 40mg
placebo capsule

Treatment: Drugs: placebo 80mg
placebo capsule

Treatment: Drugs: placebo 120mg
placebo capsule

Treatment: Drugs: placebo 180mg
placebo capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
single dose safety
Timepoint [1] 0 0
from baseline to Day10
Primary outcome [2] 0 0
multiple dose safety
Timepoint [2] 0 0
from baseline to Day18
Secondary outcome [1] 0 0
AUC0-8 after single dose
Timepoint [1] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [2] 0 0
Cmax after single dose
Timepoint [2] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [3] 0 0
t1/2 after single dose
Timepoint [3] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [4] 0 0
Tmax after single dose
Timepoint [4] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [5] 0 0
CL/F after single dose
Timepoint [5] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [6] 0 0
Vz/F after single dose
Timepoint [6] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [7] 0 0
AUC0-t after multiple dose
Timepoint [7] 0 0
Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Secondary outcome [8] 0 0
AUC0-8 after multiple dose
Timepoint [8] 0 0
Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Secondary outcome [9] 0 0
Cmax after multiple dose
Timepoint [9] 0 0
Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Secondary outcome [10] 0 0
t1/2 after multiple dose
Timepoint [10] 0 0
Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Secondary outcome [11] 0 0
Tmax after multiple dose
Timepoint [11] 0 0
Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Secondary outcome [12] 0 0
Cmin after multiple dose
Timepoint [12] 0 0
Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Secondary outcome [13] 0 0
RAAUC0-t after multiple dose
Timepoint [13] 0 0
Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Secondary outcome [14] 0 0
RACmax after multiple dose
Timepoint [14] 0 0
Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Secondary outcome [15] 0 0
effect of food on the single oral dose AUC0-8
Timepoint [15] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [16] 0 0
effect of food on the single oral dose Cmax
Timepoint [16] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [17] 0 0
effect of food on the single oral dose Tmax
Timepoint [17] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [18] 0 0
effect of food on the single oral dose t1/2
Timepoint [18] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [19] 0 0
effect of food on the single oral dose CL/F
Timepoint [19] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [20] 0 0
effect of food on the single oral dose Vz/F
Timepoint [20] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [21] 0 0
metabolites of BEBT-503 in urine
Timepoint [21] 0 0
Pre-dose to 48 hours postdose
Secondary outcome [22] 0 0
metabolites of BEBT-503 in plasma
Timepoint [22] 0 0
Pre-dose to 48 hours postdose

Eligibility
Key inclusion criteria
1. Males or females, of any race, between 18 and 55 years of age, inclusive.
2. Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) with a minimum body weight of 50 kg. Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor's approval
3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia, eg, suspicion of Gilbert's syndrome based on total and direct bilirubin, is not acceptable) at Screening and Check-in as assessed by the Investigator (or designee), as applicable.
4. Resting heart rate = 45 bpm and = 90 bpm with a single 12-lead ECG at Screening.
5. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
6. Male subjects must agree to refrain from sperm donation and females should refrain from ova donation from the date of Check-in (Day-1) until 90 days after the Follow-up visit.
7. Participants have ability to swallow and retain oral medication.
8. Able to comprehend and willing to sign an Information and Consent Form and to abide by the study restrictions.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
2. History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
4. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed, but not cholecystectomy).
5. History of malignancy (cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ are eligible).
6. Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
7. Any of the following:

1. corrected QT interval by Fridericia formula> 450 msec confirmed by repeat measurement.
2. QRS duration > 120 msec confirmed by repeat measurement.
3. PR interval > 220 msec confirmed by repeat measurement.
4. findings which would make corrected QT interval measurements difficult or corrected QT interval data uninterpretable.
5. history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
8. History of alcoholism or drug/chemical abuse within 6 months prior to Check-in.
9. Alcohol consumption of > 21 units per week for males and > 14 units per week for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
10. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check-in.
11. Positive hepatitis panel and/or positive human immunodeficiency virus (HIV) test.
12. Participation in a clinical study involving administration of an investigational agent or vaccine (new chemical entity) or having received a biological product in the past 90 days prior to dosing.
13. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
14. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
15. Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
16. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
17. Use of tobacco- or nicotine-containing products within 1 month prior to Check-in, or positive cotinine at Screening or Check-in.
18. Receipt of blood products within 2 months prior to Check-in and donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
19. Any major surgery within 4 weeks prior to first dosing.
20. Poor peripheral venous access.
21. Have previously completed or withdrawn from this study investigating BEBT-503, and have previously received the investigational product.
22. Subject who, in the opinion of the Investigator (or designee), should not participate in this study.
23. Subject is not willing to minimize or avoid exposure to natural or artificial sunlight (tanning beds or ultraviolet A/B treatment) following administration of study drug until 24 hours after the last dose.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/07/2023
Sample size
Target
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeBetter Med Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase I, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetic of orally administered BEBT-503 will be assessed in healthy adult subjects.

The study will consist of 2 parts: a SAD phase (Part A) enrolling a total of 5 cohorts of healthy subjects; a MAD phase (Part B) enrolling 2 cohorts of healthy subjects; One cohort of Part A will receive BEBT-503 under both fasted and fed conditions to investigate the effect of food
Trial website
https://clinicaltrials.gov/study/NCT05391880
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, CMO
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05391880