Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04680429
Status:
COMPLETED
Last Update Posted:
2021-08-18
First Post:
2020-12-17
Brief Title:
A Single and Multiple Ascending and Food Effect Study of RP7214 a DHODH Inhibitor in Healthy Adult Subjects
Sponsor:
Rhizen Pharmaceuticals SA
Organization:
Rhizen Pharmaceuticals SA
Study Overview
Official Title:
A Phase I Randomized Double-blind Placebo-controlled Single and Multiple Ascending Dose Study and Food Effect Study of Oral RP7214 a DHODH Inhibitor in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-08
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:
This is a randomized double-blind study to evaluate the safety tolerability and PK of single and multiple ascending oral doses of RP7214 The relative bioavailability in fed and fasting conditions will also be evaluated for RP7214 The study comprises three parts Part 1 Single ascending dose Part 2 Multiple ascending dose and Part 3 Food effect
Detailed Description:
There are three escalating cohorts in SAD part and two escalating cohorts in MAD part In each cohort six eligible healthy volunteers will be randomized to receive either RP7214 or placebo in 21 ratio Within each cohort two sentinel subjects RP7214 and Placebo will be dosed first for assessment of safety and tolerability The safety data of at least 48 hrs will be reviewed to confirm safety of sentinel subjects after which the remaining four subjects will be dosed Food effect study is a randomized 2-treatment 2-period 2-sequence crossover study in 12 HVs
Study Oversight
Has Oversight DMC:
None
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?:
None