NCT05287360

A Study Comparing Four Different Rivoceranib Tablets in Healthy Participants

A Phase 1, Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Bioequivalence of Four Formulations of Oral Rivoceranib Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Elevar Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this trial is to compare a single dose of 4 different rivoceranib tablets in healthy adult participants.

Detailed description

Participants will be randomized to 1 of 4 treatment sequences (1-4). Each participant will participate in 4 treatment periods. One formulation of rivoceranib will be administered per treatment period. Blood samples will be collected predose and up to 120 hours postdose to evaluate the pharmacokinetics (PK) of rivoceranib and its major metabolites.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rivoceranib	Rivoceranib will be supplied as film-coated tablets for oral administration as 4 different formulations: Formulation 1, 3, and 4 = 250 milligrams; Formulation 2 = 200 milligrams.

Timeline

• Start date: 2021-12-30
• Primary completion: 2022-03-16
• Completion: 2022-03-24
• First posted: 2022-03-18
• Last updated: 2022-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study