Healthy Volunteer Study Comparing Tablet and Capsule Formulations
- Registration Number
- NCT04001998
- Lead Sponsor
- Blade Therapeutics
- Brief Summary
Single center, randomized, open label, two-part crossover study designed to evaluate the PK, food effect, dose proportionality, safety, and tolerability of BLD-2660 in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Able to provide written informed consent
- Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing
- Normal BMI (18 to ≤ 35 kg/m2)
- Have a negative urine drug screen/alcohol breath test on admission to clinic
- Agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 90 days following completion of dosing
- Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test on Day -1
- Be in general good health
- Clinical laboratory values within normal range
Exclusion Criteria
- Recent 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 subject will complete the study per protocol
- History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period
- Blood donation or significant blood loss within 30 days prior to the first study drug administration
- Plasma donation within 7 days prior to the first study drug administration
- Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer
- Females who are pregnant or lactating
- Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant
- Failure to satisfy the PI of fitness to participate for any other reason
- Active infection or history of recurrent infections
- Active malignancy and history of malignancy in the past 2 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia
- Antibiotic treatment within 3 months
- Chronic medical condition
- Any acute illness within 30 days prior
Other protocol defined inclusion/exclusion criteria could apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dose Proportionality BLD-2660 Single oral dose of BLD-2660 tablet formulation Tablet vs Capsule Formulation BLD-2660 Single oral dose of BLD-2660 capsule or tablet formulation
- Primary Outcome Measures
Name Time Method Apparent terminal elimination rate constant (Kel) Up to 40 days Measured by plasma concentration
Time of the maximum drug concentration (Tmax) Up to 40 days Measured by plasma concentration
Apparent terminal half-life (t½) Up to 40 days Measured by plasma concentration
AUC from time 0 to infinity (AUC0-inf) Up to 40 days Measured by plasma concentration
Maximum observed drug concentration (Cmax) Up to 40 days Measured by plasma concentration
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) Up to 40 days Measured by plasma concentration
- Secondary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Up to 40 days AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
Trial Locations
- Locations (1)
Scientia Clinical Research
🇦🇺Randwick, New South Wales, Australia