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

NCT04138836 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-01-18

No results posted yet for this study

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

DRUG

BBT-877

BBT-877 oral capsule.

DRUG

Midazolam

Midazolam oral syrup.

DRUG

Itraconazole

Itraconazole oral capsule.

DRUG

Esomeprazole

Esomeprazole oral capsule.

Sponsors & Collaborators

  • KCRN Research, LLC

    collaborator INDUSTRY

  • Bridge Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeong-Hyun Ryou, M.D., Ph.D. · Bridge Biotherapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2019-11-04
Completion
2019-11-04
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 NCT04138836 on ClinicalTrials.gov