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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05667688




Registration number
NCT05667688
Ethics application status
Date submitted
15/11/2022
Date registered
28/12/2022

Titles & IDs
Public title
Pharmacokinetics and Pharmacodynamics Study of LBS-008 in Healthy Volunteers Aged 50-85
Scientific title
A Phase 1b, Open-Label, Parallel Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Tinlarebant in Healthy Volunteers Aged 50-85
Secondary ID [1] 0 0
LBS-008-CT06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Dry Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tinlarebant (LBS-008)

Active comparator: Cohort 1: 5 mg, fasted - A single dose (5 mg) of tinlarebant will be administered to each study participant on study Day 1.

Active comparator: Cohort 2: 10 mg, fasted - A single dose (10 mg) of tinlarebant will be administered to each study participant on study Day 1.


Treatment: Drugs: Tinlarebant (LBS-008)
A single dose of Tinlarebant (LBS-008) will be administered to each study participant on study Day 1.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Timepoint [1] 0 0
Up to 168 hours
Primary outcome [2] 0 0
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Timepoint [2] 0 0
Up to 168 hours
Primary outcome [3] 0 0
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Timepoint [3] 0 0
Up to 168 hours
Primary outcome [4] 0 0
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Timepoint [4] 0 0
Up to 168 hours
Primary outcome [5] 0 0
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Timepoint [5] 0 0
Up to 168 hours
Primary outcome [6] 0 0
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Timepoint [6] 0 0
Up to 168 hours
Primary outcome [7] 0 0
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Timepoint [7] 0 0
Up to 168 hours
Primary outcome [8] 0 0
To measure the pharmacokinetics (PK) of tinlarebant in plasma following a single oral dose in healthy volunteers aged 50-85.
Timepoint [8] 0 0
Up to 168 hours
Primary outcome [9] 0 0
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Timepoint [9] 0 0
Up to 168 hours
Primary outcome [10] 0 0
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Timepoint [10] 0 0
Up to 168 hours
Primary outcome [11] 0 0
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Timepoint [11] 0 0
Up to 168 hours
Primary outcome [12] 0 0
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Timepoint [12] 0 0
Up to 168 hours
Primary outcome [13] 0 0
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Timepoint [13] 0 0
Up to 168 hours
Primary outcome [14] 0 0
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Timepoint [14] 0 0
Up to 168 hours
Primary outcome [15] 0 0
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Timepoint [15] 0 0
Up to 168 hours
Primary outcome [16] 0 0
To measure the concentrations of retinol-binding protein 4 (RBP4), a pharmacodynamic (PD) biomarker, in plasma following a single oral dose in healthy volunteers aged 50-85
Timepoint [16] 0 0
Up to 168 hours
Secondary outcome [1] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [1] 0 0
Up to 15 days
Secondary outcome [2] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [2] 0 0
Up to 15 days
Secondary outcome [3] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [3] 0 0
Up to 15 days
Secondary outcome [4] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [4] 0 0
Up to 15 days
Secondary outcome [5] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [5] 0 0
Up to 15 days
Secondary outcome [6] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [6] 0 0
Up to 15 days
Secondary outcome [7] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [7] 0 0
Up to 15 days
Secondary outcome [8] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [8] 0 0
Up to 15 days
Secondary outcome [9] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [9] 0 0
Up to 15 days
Secondary outcome [10] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [10] 0 0
Up to 15 days
Secondary outcome [11] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [11] 0 0
Up to 15 days
Secondary outcome [12] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [12] 0 0
Up to 15 days
Secondary outcome [13] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [13] 0 0
Up to 15 days
Secondary outcome [14] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [14] 0 0
Up to 15 days
Secondary outcome [15] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [15] 0 0
Up to 15 days
Secondary outcome [16] 0 0
To investigate the systemic and ocular safety and tolerability of a single oral dose of tinlarebant in healthy adult volunteers aged 50-85.
Timepoint [16] 0 0
Up to 15 days

Eligibility
Key inclusion criteria
Key inclusion criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2. Healthy adult male or female, or adult male or female with a stable chronic disease or condition aged 50-85 years of age, inclusive. Adults with stable chronic disease or condition includes adults with no new diagnosis, hospitalisation or changes in medication in the 3 months prior to first dose of study drug on Day 1. Ongoing concomitant medications associated with the stable disease or condition, including over-the-counter (OTC) medications and herbal/vitamin supplements taken by volunteers, will be recorded and reviewed by the PI (or delegate) to determine whether the volunteer is suitable for inclusion in the study. In conducting this review, the PI (or delegate) must consider
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria 11, 12, 13 and 14.
3. The volunteer is considered by the Investigator to be in stable health

Key exclusion criteria :

1. Presence of CS cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, or any other condition that, in the opinion of the Investigator, would jeopardise the safety of the participant or the validity of the study results.
2. Had a CS new illness within 1 month prior to the screening visit, with the exception of fully resolved gastrointestinal illness at least 14 days prior to the screening visit, fully resolved minor colds (e.g., only cold and flu-like symptoms) that occurred within 1 month prior to the screening visit, and fully resolved corona virus disease 2019 (COVID-19) infections if resolved at least 14 days prior to the screening visit and 30 days prior to confinement to the clinical facility.
3. A history of uncontrolled hypertension, coronary artery disease, or any other significant cardiovascular disease.
4. A history of uncontrolled diabetes. Volunteers with fully resolved gestational diabetes will be eligible to participate in the study.
5. A history of unexplained loss of consciousness, epilepsy or other seizure disorder, or cerebrovascular disease.

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
28/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/01/2023
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RBP4 Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Belite Bio, Inc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Francis
Address 0 0
Nucleus Network - Melbourne
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
After completion of the study, data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the investigators to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and any other related issues. The sponsor has final approval authority of all such issues. Data are the property of the sponsor and cannot be published without their prior authorization, but data and any publication thereof will not be unduly withheld.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05667688