Study to Evaluate the Pharmacokinetics of Oral Sparsentan Suspension

Sponsor
Travere Therapeutics, Inc.
Study ID
NCT05562362
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • RE-021, sparsentan — DRUG
    RE-021, sparsentan - Subjects will be randomized 1 of 3 dose level

Study Details

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.

Key Dates

Start date
Jun 18, 2020
Status verified
Jun 2022
Primary completion
Nov 12, 2020
Completion
Nov 12, 2020

Study Design

Enrollment
47 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Fasted State
    Sparsentan will be administered in 3-dose level in healthy subjects. Subjects will be randomized to 1 of 3 dose levels (200mg, 400mg and 800 mg) and will receive a single dose of sparsentan in the fasted state on Period 1, Day 1 (Study Day 1)
  • Experimental: Fed State
    Sparsentan will be administered in 3-dose level in healthy subjects. Subjects will have a single dose of sparsentan (200mg, 400mg and 800 mg) in the fed state (high-fat breakfast) on Period 2, Day 1 (Study Day 8)
  • Experimental: Fed State - Multiple
    Sparsentan will be administered in 3-dose level in healthy subjects. Subjects will have multiple doses of sparsentan (200mg, 400mg and 800 mg) in the fed state on Period 3, Days 1 to 14 (Study days 12 to 25)

Primary Outcome Measure

Assessment of single-dose pharmacokinetics of sparsentan oral suspension dosed in fed and fasted states - Cmax [ Time Frame: Study Days 1 and 8 ]

Related Studies