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

NCT04939467 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-04-15

No results posted yet for this study

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

Conditions

  • Drug Drug Interaction

Interventions

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

Sponsors & Collaborators

  • Blade Therapeutics

    lead INDUSTRY

Principal Investigators

  • Kimberly S Cruz, MD · Advanced Pharma CR, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2021-12-16
Completion
2022-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939467 on ClinicalTrials.gov