Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations
Study Details
Study Description
Brief Summary
A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: BLD-0409
Randomized to active product.
|
| 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). |
Drug: BLD-0409
Randomized to active product.
|
Outcome Measures
Primary Outcome Measures
- Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) [Up to 16 days]
Measured by plasma concentration
- Maximum observed drug concentration (Cmax) [Up to 16 days]
Measured by plasma concentration
Eligibility Criteria
Criteria
Inclusion Criteria:
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.
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Participants must have clinical laboratory values within normal ranges or < 1.2 times upper limit of normal (ULN) as specified by the testing laboratory.
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Body mass index (BMI) 18 to ≤ 32 kg/m2.
Reproductive Considerations
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Use of acceptable contraception.
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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.
Exclusion Criteria:
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.
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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.
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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.
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Serious local or systemic infection within 1 month of Screening requiring antibiotic treatment or history of recurrent infections.
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Surgery within the past 3 months prior to the first study drug administration determined by the Investigator to be clinically relevant.
Diagnostic Assessments
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Positive for human immunodeficiency virus (HIV) antibody or antigen.
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Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
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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).
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Heart rate < 40 beats per minute (bpm) or > 100 bpm at Screening.
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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.
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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
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Significant weight loss or gain between Screening and first study drug administration.
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Blood donation or significant blood loss within 60 days prior to the first study drug administration.
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Plasma donation within 7 days prior to the first study drug administration.
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Females who are pregnant or breastfeeding.
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Diets that could alter metabolism (i.e., high protein, Slim Fast®, Nutrisystem®, etc.) within 7 days prior first study drug administration.
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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.
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Positive urine drug screen/alcohol breath test at Day -1 (admission).
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Intake of alcohol or caffeine-containing products from 48 hours before first study drug administration through the EOS visit.
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Active smokers and users of nicotine-containing products.
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Failure to satisfy the Investigator of fitness to participate for any other reason.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Scientia Clinical Research | Randwick | New South Wales | Australia | 2031 |
Sponsors and Collaborators
- Blade Therapeutics
Investigators
- Principal Investigator: Christopher Argent, MD, Scientia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B-0409-102