NCT04939467

Dedicated Drug-Drug Interaction (DDI) Study in Healthy Volunteers

A Phase 1, Open-Label, Non-Randomized, Fixed Sequence Study to Evaluate the Steady-state Pharmacokinetics of BLD-0409, Nintedanib and Pirfenidone When Administered Concurrently in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Blade Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Open-Label, Non-Randomized, Fixed Sequence Study to Evaluate the Steady-state Pharmacokinetics of BLD-0409, Nintedanib and Pirfenidone when Administered Concurrently in Healthy Volunteers

Detailed description

This is a single-center, open-label study designed to determine the effect of BLD-0409 on the PK of nintedanib and pirfenidone, all at steady state, and to evaluate the safety and tolerability of BLD-0409 administered with either nintedanib or pirfenidone in healthy adult volunteers

Conditions

• Drug Drug Interaction

Interventions

Type	Name	Description
DRUG	Pirfenidone 267 mg Oral Tablet	Fixed sequence use of active product, TID
DRUG	Nintedanib 150 mg Oral Capsule	Fixed sequence use of active product, BID
DRUG	BLD-0409 750 mg Oral Tablet	Fixed sequence use of active product, QD

Timeline

• Start date: 2021-10-15
• Primary completion: 2021-12-16
• Completion: 2022-04-01
• First posted: 2021-06-25
• Last updated: 2022-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study