A phase I, open-label, randomized, three-way cross-over study comparing bioavailability of two formulations and assessing the food effect on tablet formulation after PXL770 single oral dose in healthy subjects

A phase I, open-label, randomized, three-way cross-over study comparing bioavailability of two formulations and assessing the food effect on tablet formulation after PXL770 single oral dose in healthy subjects - Bioavailability of two formulations of PXL770 after a single dose in HV

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49206

Enrollment

Registered

2020-08-31

Start date

2020-09-17

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

The volunteer will receive 250 mg PXL770, 3 times over the course of 3 periods. PXL770 will be administered twice as a tablet formulation and once as a capsule formulation. Each administration will

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 kg/m2, inclusive, at screening. 4. Weight : >=50 kg at screening. 5. Status : healthy subjects.

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 (e.g. persons kept in detention). 5. History of relevant drug and/or food allergies.

Design outcomes

Primary

Measure	Time frame
To assess and compare PXL770 relative bioavailability (rBA) and primary pharmacokinetic (PK) parameters (Cmax, tmax, AUC0-t, AUCinf) between tablet and capsule formulations after a single oral dose of 250 mg	—

Secondary

Measure	Time frame
- To compare PXL770 secondary PK parameters between tablet and capsule formulations after a single oral dose of 250 mg - To assess the effect of food on the PK parameters (Cmax, tmax, AUC0-t, AUCinf) of the tablet formulation - To assess the safety and tolerability of PXL770 after a single oral dose of tablet and capsule formulations	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)