A phase 1, open-label, fixed-sequence, drug-drug interaction study between multiple oral doses of Inarigivir Soproxil and a single oral dose of midazolam in healthy subjects

Completed

• Conditions: 10019654; Hepatitis B; Hepatitis B virus infection

• Registration Number: NL-OMON46790
• Lead Sponsor: Spring Bank Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

-Healthy male or female subjects
-18-55 years, inclusive, at screening
-BMI 18.0-30.0 kg/m2, inclusive, at screening
-Females must be non-pregnant, non-lactating and of non childbearing potential

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the effect of steady-state oral inarigivir on the single dose<br /><br>pharmacokinetics (PK) of oral midazolam in healthy subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of a single oral dose of midazolam, a<br /><br>single oral dose of inarigivir, and multiple oral doses of inarigivir<br /><br>administered without and with a single oral dose of midazolam in healthy<br /><br>subjects.<br /><br><br /><br>To assess the PK of inarigivir after single and multiple oral doses in healthy<br /><br>subjects.<br /><br><br /><br>Exploratory:<br /><br>To evaluate the pharmacodynamics (PD) following single and multiple oral doses<br /><br>of inarigivir in healthy subjects.</p><br>