NCT04138836

Assess the Drug Interactions of BBT-877 and Midazolam, Itraconazole, and Esomeprazole in Healthy Adult Subjects

A 3-Part, Phase 1 Study to Assess the Drug Interactions of BBT-877 and Midazolam, Itraconazole, and Esomeprazole in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Bridge Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Study to determine the effect of multiple-dose BBT-877 on the single-dose pharmacokinetics of midazolam, the safety and tolerability of a single dose of BBT-877 administered alone and with multiple doses of itraconazole, and the effect of multiple-dose esomeprazole on the single-dose pharmacokinetics of BBT-877, in healthy adult subjects.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	BBT-877	BBT-877 oral capsule.
DRUG	Midazolam	Midazolam oral syrup.
DRUG	Itraconazole	Itraconazole oral capsule.
DRUG	Esomeprazole	Esomeprazole oral capsule.

Timeline

• Start date: 2019-09-17
• Primary completion: 2019-11-04
• Completion: 2019-11-04
• First posted: 2019-10-25
• Last updated: 2020-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study