Study to Evaluate the Pharmacokinetics of Oral Sparsentan Suspension

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Healthy Subjects

Clinical Trial Details

NCT number	NCT05562362
Study type	Interventional
Source	Travere Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	June 18, 2020
Completion date	November 12, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.