An open-label, 4-arms study to assess the drug-drug interaction of PXL770 with repaglinide, tolbutamide, midazolam, and caffeine in healthy subjects

An open-label, 4-arms study to assess the drug-drug interaction of PXL770 with repaglinide, tolbutamide, midazolam, and caffeine in healthy subjects - DDI study PXL770 with repaglinide, tolbutamide, midazolam, and caffeine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50829

Enrollment

Registered

2021-02-15

Start date

2021-04-06

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

NASH Non-alcoholic steatohepatitis

Interventions

Subjects will be given PXL770 and repaglinide (Group 1), PXL770 and tolbutamide (Group 2), PXL770 and midazolam (Group 3), or PXL770 and caffeine (Group 4). On the day that both PXL770 and repaglini

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Gender: male or female. 2. Age: 18 to 55 years, inclusive, at screening. 3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive. at screening. 4. Weight: >=50 kg at screening. 5. Status: healthy subjects. 6. Race: Caucasian.

Exclusion criteria

Exclusion criteria: 1. Previous participation in any clinical study with PXL770 (only if subject received study drug). 2. Employee of PRA or the Sponsor. 3. Mental handicap, legal incapacity, or any history of clinically important emotional and/or psychiatric illness. 4. Vulnerable subjects (eg, persons kept in detention). 5. History of relevant drug and/or food allergies.

Design outcomes

Primary

Measure	Time frame
To assess the effect of repeated doses of PXL770 on the primary pharmacokinetics (PK) parameters of repaglinide, tolbutamide, midazolam, and caffeine in healthy subjects.	—

Secondary

Measure	Time frame
To assess the safety and tolerability of PXL770 with and without coadministration of repaglinide, tolbutamide, midazolam, and caffeine in healthy subjects. To assess the effect of repeated doses of PXL770 on the secondary PK parameters of repaglinide, tolbutamide, midazolam, and caffeine in healthy subjects. To assess PK parameters of PXL770 after repeated dosing. To assess the effect of repeated doses of PXL770 on the PK parameters of midazolams metabolite 1 hydroxymidazolam in healthy subjects. To assess the effect of repeated doses of PXL770 on the PK parameters of caffeine*s metabolite paraxanthine in healthy subjects.	—

Measure

Time frame

To assess the safety and tolerability of PXL770 with and without coadministration of repaglinide, tolbutamide, midazolam, and caffeine in healthy subjects. To assess the effect of repeated doses of PXL770 on the secondary PK parameters of repaglinide, tolbutamide, midazolam, and caffeine in healthy subjects. To assess PK parameters of PXL770 after repeated dosing. To assess the effect of repeated doses of PXL770 on the PK parameters of midazolam*s metabolite 1* hydroxymidazolam in healthy subjects. To assess the effect of repeated doses of PXL770 on the PK parameters of caffeine*s metabolite paraxanthine in healthy subjects.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)