Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT05287360
Status:
COMPLETED
Last Update Posted:
2022-04-18
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Four Different Rivoceranib Tablets in Healthy Participants
Sponsor:
Elevar Therapeutics
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: