Status:
COMPLETED
Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations
Lead Sponsor:
Blade Therapeutics
Conditions:
Relative Bioavailability
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 consist...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
May 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04814472
Start Date
May 16 2021
End Date
November 3 2021
Last Update
November 10 2021
Active Locations (1)
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1
Scientia Clinical Research
Randwick, New South Wales, Australia, 2031