Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-29 @ 9:47 AM
Study NCT ID:
NCT02364635
Status:
COMPLETED
Last Update Posted:
2015-09-29
First Post:
2015-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Icosabutate - A Phase I, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
Sponsor:
Pronova BioPharma
Organization:
Study Overview
Official Title:
PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2015-09
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:
PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
Objective:
* To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects
* To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects
Objective:
* To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects
* To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: