Healthy Volunteer Study Comparing Tablet and Capsule Formulations

Study Overview
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Brief Summary
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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.

Official Title
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A Two-Part, Open Label, Complete Crossover Study to Compare the Tablet and Capsule Formulations of BLD-2660, Including a Food Effect Assessment of the Tablet Formulation, and to Assess Dose Proportionality Following Single Oral Doses of BLD-2660 in Tablet Formulation

Conditions
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Fibrosis

Intervention / Treatment
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* Drug: BLD-2660


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tablet vs Capsule Formulation<br>Single oral dose of BLD-2660 capsule or tablet formulation | Drug: BLD-2660<br>* Randomized to active product<br>|
| Experimental: Dose Proportionality<br>Single oral dose of BLD-2660 tablet formulation | Drug: BLD-2660<br>* Randomized to active product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) | Measured by plasma concentration | Up to 40 days | 
| AUC from time 0 to infinity (AUC0-inf) | Measured by plasma concentration | Up to 40 days | 
| Maximum observed drug concentration (Cmax) | Measured by plasma concentration | Up to 40 days | 
| Time of the maximum drug concentration (Tmax) | Measured by plasma concentration | Up to 40 days | 
| Apparent terminal half-life (t½) | Measured by plasma concentration | Up to 40 days | 
| Apparent terminal elimination rate constant (Kel) | Measured by plasma concentration | Up to 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) | AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events | Up to 40 days |