Relative Bioavailability
Conditions
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 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.
Interventions
DRUGBLD-0409
Randomized to active product.
Sponsors
Blade Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Exclusion criteria
Participants meeting ANY of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia
Outcome results
None listed