Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations
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|ClinicalTrials.gov Identifier: NCT04814472|
Recruitment Status : Active, not recruiting
First Posted : March 24, 2021
Last Update Posted : July 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Relative Bioavailability||Drug: BLD-0409||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers|
|Actual Study Start Date :||May 16, 2021|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||November 2021|
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.
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).
Randomized to active product.
- Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last) [ Time Frame: Up to 16 days ]Measured by plasma concentration
- Maximum observed drug concentration (Cmax) [ Time Frame: Up to 16 days ]Measured by plasma concentration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04814472
|Australia, New South Wales|
|Scientia Clinical Research|
|Randwick, New South Wales, Australia, 2031|
|Principal Investigator:||Christopher Argent, MD||Scientia|