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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04814472




Registration number
NCT04814472
Ethics application status
Date submitted
22/03/2021
Date registered
24/03/2021

Titles & IDs
Public title
Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations
Scientific title
A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers
Secondary ID [1] 0 0
B-0409-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relative Bioavailability 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BLD-0409

Experimental: Oral Solution vs. Tablet Formulation - There will be 3 treatments, each single dose administered based on the treatment sequence with at least a 3 day washout between treatments:

Treatment A: 750 mg BLD-0409 oral solution formulation (solution) under fasting conditions.

Treatment B: 750 mg BLD-0409 tablet formulation (3 x 250 mg tablets) under fasting conditions.

Treatment C: 750 mg BLD-0409 tablet formulation (3 x 250 mg tablets) under fed conditions.

Experimental: Tablet Formulation Dose Proportionality - There will be 4 treatments, each single dose administered under fed conditions (standard meal) based on the treatment sequence with at least a 3 day washout between treatments:

Treatment A: 250 mg BLD-0409 tablet formulation (1 x 250 mg tablet).

Treatment B: 500 mg BLD-0409 tablet formulation (2 x 250 mg tablet).

Treatment C: 750 mg BLD-0409 tablet formulation (3 x 250 mg tablet).

Treatment D: 1000 mg BLD-0409 tablet formulation (4 x 250 mg tablet).


Treatment: Drugs: BLD-0409
Randomized to active product.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
Timepoint [1] 0 0
Up to 16 days
Primary outcome [2] 0 0
Maximum observed drug concentration (Cmax)
Timepoint [2] 0 0
Up to 16 days

Eligibility
Key inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria apply:

Age and Gender

1. Male and female participants 18-55 years of age (inclusive) at the time of signing the PICF.

Diagnosis and disease characteristics
2. Participants must be in good general health, in the opinion of the Investigator, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, and/or before administration of the initial dose of study drug.
3. Participants must have clinical laboratory values within normal ranges or < 1.2 times upper limit of normal (ULN) as specified by the testing laboratory.
4. Body mass index (BMI) 18 to = 32 kg/m2.

Reproductive Considerations
5. Use of acceptable contraception.
6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. Females not of childbearing potential must be surgically infertile or post-menopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle-stimulating hormone (FSH) level > 40 mIU/mL at Screening.

Informed Consent
7. Participants must provide signed informed consent prior to study entry and have the ability and willingness to attend and comply with the necessary visits at the study site.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants meeting ANY of the following exclusion criteria are NOT eligible to be randomized into the study:

Medical Conditions

1. Recent (less than 6 weeks) wound, or presence of an ongoing non-healing skin wound.
2. Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will complete the study per protocol.
3. Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low grade cervical intraepithelial neoplasia.
4. Serious local or systemic infection within 1 month of Screening requiring antibiotic treatment or history of recurrent infections.
5. Surgery within the past 3 months prior to the first study drug administration determined by the Investigator to be clinically relevant.

Diagnostic Assessments
6. Positive for human immunodeficiency virus (HIV) antibody or antigen.
7. Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
8. Systolic blood pressure (BP) > 150 mmHg or < 90 mmHg or diastolic BP > 90 mmHg or < 50 mmHg at Screening with one repeat allowed per the Investigator's discretion at Screening and Day -1 (Period 1).
9. Heart rate < 40 beats per minute (bpm) or > 100 bpm at Screening.
10. Prolonged QT interval corrected by Fridericia's formula (QTcF) (> 450 ms for males and > 470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting ECG, as judged by the Investigator.
11. Females with heavy menstruating cycles and borderline-low iron studies.

Prior Therapy
12. All prescription and over the counter medications (including herbal medications), except for non-estrogen contraceptives, are prohibited within 7 days prior to the first study drug administration and throughout the entire duration of the study.
13. Any estrogen-containing products, e.g., contraceptives, patch, cream, implants within 14 days prior to the first study drug administration.

Prior/Concurrent Clinical Study Experience
14. Administration of investigational product in another study within 30 days prior to the first study drug administration, or five half-lives, whichever is longer.

Other Exclusions
15. Significant weight loss or gain between Screening and first study drug administration.
16. Blood donation or significant blood loss within 60 days prior to the first study drug administration.
17. Plasma donation within 7 days prior to the first study drug administration.
18. Females who are pregnant or breastfeeding.
19. Diets that could alter metabolism (i.e., high protein, Slim Fast®, Nutrisystem®, etc.) within 7 days prior first study drug administration.
20. History or presence of alcohol or drug abuse (including recreational marijuana use) within the 1 year prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period.
21. Positive urine drug screen/alcohol breath test at Day -1 (admission).
22. Intake of alcohol or caffeine-containing products from 48 hours before first study drug administration through the EOS visit.
23. Active smokers and users of nicotine-containing products.
24. Failure to satisfy the Investigator of fitness to participate for any other reason.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
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
16/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/11/2021
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Blade Therapeutics
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Christopher Argent, MD
Address 0 0
Scientia
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


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/NCT04814472