NCT05562362

Study to Evaluate the Pharmacokinetics of Oral Sparsentan Suspension

A Three Way Sequential, Randomised, Open-Label Study Designed to Evaluate the Single and Multiple-Dose Pharmacokinetics and the Effect of Food on the Single-Dose Pharmacokinetics of Oral Sparsentan Suspension in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Travere Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This single-center, open-label, randomized, single and multiple-dose, 3-way sequential study at 3 dose levels will be performed in healthy subjects. Subjects will be randomized to 1 of the 3 dose levels. In each dose level, subjects will be administered a single dose in the fasted state and then a single dose in the fed state, followed by 14 days of dosing to assess Pharmacokinetics (PK) following multiple dosing.

Detailed description

This is a single-center, open-label, randomized, single- and multiple-dose, 3-way sequential study at 3 dose levels in healthy subjects. For logistical purposes subjects will be admitted to the unit to be dosed in groups of approximately 16 or fewer. Subjects will be randomized into one of the three dose levels. Within each dose level, subjects will be administered a single dose in the fasted state and then a single dose in the fed state, followed by 14 days of dosing to assess PK following multiple dosing. Subjects will undergo preliminary screening procedures for the study at the screening visit (Day -28 to Day -2). Subjects will be admitted to the clinical unit on the evening prior to investigational medicinal product (IMP) administration (Day -1) and will remain on site until 72 h post-final dose. Subjects will receive a single dose of sparsentan in the fasted state on Period 1, Day 1 (Study day 1) and a single dose of sparsentan in the fed state (high-fat breakfast) on Period 2, Day 1 (Study day 8), followed by multiple doses of sparsentan in the fed state on Period 3, Day 1 to 14 (Study days 12 to 25). On PK sampling days for the multiple dose treatment period (Period 3, Days 7, and 14; Study days 18 and 25), subjects will consume a high-fat breakfast before dosing; on other days, a standard breakfast will be provided. A follow-up phone call will take place 5 to 7 days post-final dose to ensure the ongoing wellbeing of the subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	RE-021, sparsentan	RE-021, sparsentan - Subjects will be randomized 1 of 3 dose level

Timeline

• Start date: 2020-06-18
• Primary completion: 2020-11-12
• Completion: 2020-11-12
• First posted: 2022-09-30
• Last updated: 2022-09-30

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study