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

Completed

• Conditions: ASH; Non-alcoholic steatohepatitis; 10019654

• Registration Number: NL-OMON49206
• Lead Sponsor: Poxel SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-06-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess and compare PXL770 relative bioavailability (rBA) and primary<br /><br>pharmacokinetic (PK) parameters (Cmax, tmax, AUC0-t, AUCinf) between tablet and<br /><br>capsule formulations after a single oral dose of 250 mg</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To compare PXL770 secondary PK parameters between tablet and capsule<br /><br>formulations after a single oral dose of 250 mg<br /><br>- To assess the effect of food on the PK parameters (Cmax, tmax, AUC0-t,<br /><br>AUCinf) of the tablet formulation<br /><br>- To assess the safety and tolerability of PXL770 after a single oral dose of<br /><br>tablet and capsule formulations</p><br>