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

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 - SB-9200/midazolam DDI

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46790

Enrollment

Registered

2018-03-13

Start date

2018-05-07

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Hepatitis B virus infection

Interventions

During the study the volunteer will receive a single dose and multiple doses of inarigivir and 2 single doses of midazolam. Inarigivir will be given as oral tablets and midazolam will be given as an

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
To assess the effect of steady-state oral inarigivir on the single dose pharmacokinetics (PK) of oral midazolam in healthy subjects.	—

Secondary

Measure	Time frame
To evaluate the safety and tolerability of a single oral dose of midazolam, a single oral dose of inarigivir, and multiple oral doses of inarigivir administered without and with a single oral dose of midazolam in healthy subjects. To assess the PK of inarigivir after single and multiple oral doses in healthy subjects. Exploratory: To evaluate the pharmacodynamics (PD) following single and multiple oral doses of inarigivir in healthy subjects.	—

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)