NCT04814472

Healthy Volunteer Study Comparing Tablet and Oral Solution Formulations

A Two-Part, Open-Label, Crossover, Bioavailability Study Comparing Tablet and Oral Solution Formulations of BLD-0409 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Blade Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Relative Bioavailability

Interventions

Type	Name	Description
DRUG	BLD-0409	Randomized to active product.

Timeline

• Start date: 2021-05-16
• Primary completion: 2021-08-17
• Completion: 2021-11-03
• First posted: 2021-03-24
• Last updated: 2021-11-10

Locations

1 site across 1 country: Australia