Relative BioavailabilityPhase 1NCT04814472
Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations
A Phase 1 study testing BLD-0409 in people with Relative Bioavailability, run by Blade Therapeutics at 1 site in Australia.
Trial summary
A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Relative Bioavailability
- What is being tested?
- BLD-0409
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteAustralia
- Study dates
- 16 May 2021to 3 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Age and Gender
- Male and female participants 18-55 years of age (inclusive) at the time of signing the PICF.
- Diagnosis and disease characteristics
- 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.
- Participants must have clinical laboratory values within normal ranges or < 1.2 times upper limit of normal (ULN) as specified by the testing laboratory.
Show all 12Show fewer
- Body mass index (BMI) 18 to ≤ 32 kg/m2.
- Reproductive Considerations
- Use of acceptable contraception.
- 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
- 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.
Who cannot join
- Participants meeting ANY of the following exclusion criteria are NOT eligible to be randomized into the study:
- Medical Conditions
- Recent (less than 6 weeks) wound, or presence of an ongoing non-healing skin wound.
- 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.
- 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.
- Serious local or systemic infection within 1 month of Screening requiring antibiotic treatment or history of recurrent infections.
Show all 30Show fewer
- Surgery within the past 3 months prior to the first study drug administration determined by the Investigator to be clinically relevant.
- Diagnostic Assessments
- Positive for human immunodeficiency virus (HIV) antibody or antigen.
- Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
- 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).
- Heart rate < 40 beats per minute (bpm) or > 100 bpm at Screening.
- 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.
- Females with heavy menstruating cycles and borderline-low iron studies.
- Prior Therapy
- 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.
- 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
- 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
- Significant weight loss or gain between Screening and first study drug administration.
- Blood donation or significant blood loss within 60 days prior to the first study drug administration.
- Plasma donation within 7 days prior to the first study drug administration.
- Females who are pregnant or breastfeeding.
- Diets that could alter metabolism (i.e., high protein, Slim Fast®, Nutrisystem®, etc.) within 7 days prior first study drug administration.
- 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.
- Positive urine drug screen/alcohol breath test at Day -1 (admission).
- Intake of alcohol or caffeine-containing products from 48 hours before first study drug administration through the EOS visit.
- Active smokers and users of nicotine-containing products.
- Failure to satisfy the Investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers
A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers
Read the detailed description
The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of two oral formulations of BLD-0409, tablet and solution, in healthy volunteers (HV).
The study consists of two parts:
Part 1: A randomized, open-label, 3-period, 6-sequence, complete crossover study with at least 3-day washout between treatment periods comparing oral solution formulation to tablet formulation.
Part 2: A randomized, open-label, 4-period, 4-sequence, complete crossover study with at least 3-day washout between treatment periods evaluating single ascending doses of tablet formulation.
- Conditions
- Relative Bioavailability
- Being tested
- BLD-0409
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLD-0409Drug
Randomized to active product.
| Study group | Role | What they receive |
|---|---|---|
| Oral Solution vs. Tablet Formulation | Experimental | 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. Receives: Drug: BLD-0409 |
| Tablet Formulation Dose Proportionality | Experimental | 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). Receives: Drug: BLD-0409 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
Measured by plasma concentration
Measured: Up to 16 days
Maximum observed drug concentration (Cmax)
Measured by plasma concentration
Measured: Up to 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start16 May 2021
- Primary completion17 Aug 2021
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relative BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blade Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Argent, MD, Principal investigator, Scientia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814472
- Sponsor's protocol ID
- B-0409-102
- Status last verified
- Nov 2021
- First submitted
- 22 Mar 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04814472
- Acronym / sponsor ID
- B-0409-102
- Conditions
- Relative Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Blade TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 May 2021 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers
Detailed description
The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of two oral formulations of BLD-0409, tablet and solution, in healthy volunteers (HV).
The study consists of two parts:
Part 1: A randomized, open-label, 3-period, 6-sequence, complete crossover study with at least 3-day washout between treatment periods comparing oral solution formulation to tablet formulation.
Part 2: A randomized, open-label, 4-period, 4-sequence, complete crossover study with at least 3-day washout between treatment periods evaluating single ascending doses of tablet formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Solution vs. Tablet Formulation | Experimental | Drug: BLD-0409There 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. |
| Tablet Formulation Dose Proportionality | Experimental | Drug: BLD-0409There 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Age and Gender
- Male and female participants 18-55 years of age (inclusive) at the time of signing the PICF.
- Diagnosis and disease characteristics
- 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.
Key exclusion criteria (30 listed)
- Participants meeting ANY of the following exclusion criteria are NOT eligible to be randomized into the study:
- Medical Conditions
- Recent (less than 6 weeks) wound, or presence of an ongoing non-healing skin wound.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BLD-0409Randomized to active product. | Drug | Oral Solution vs. Tablet Formulation, Tablet Formulation Dose Proportionality |
Primary outcome
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
Time frame: Up to 16 days
Measured by plasma concentration
Maximum observed drug concentration (Cmax)
Time frame: Up to 16 days
Measured by plasma concentration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Relative Bioavailability
RecruitingPhase 1
A Study to Evaluate Different Oral Formulations of KT-621
Healthy Participants
RecruitingPhase 1
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
Healthy
RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 1
A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)
Psoriasis, Healthy
Active, not recruitingPhase 1
A Phase 1 Relative Bioavailability Study of a VX-581 Tablet Formulation
Cystic Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Argent, MD principal investigator
Scientia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BLD-0409 in people with Relative Bioavailability, run by Blade Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) (time frame: Up to 16 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.