Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-03-06 @ 12:44 PM
Study NCT ID:
NCT01998659
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2013-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Oral Dose Phase I Study With Px-102
Sponsor:
Phenex Pharmaceuticals AG
Organization:
Study Overview
Official Title:
A Double-blind, Randomized, Placebo-controlled, Dose-escalation Study of the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of Px-102 to Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2013-11
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 purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102 in healthy subjects after single oral dosing.
Detailed Description:
The study is a single-centre, double-blind, randomized, placebo-controlled, parallel group phase I study with healthy male subjects receiving ascending single oral oral doses of Px-102 to assess the safety and tolerability, pharmacokinetics and pharmacodynamics.
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?: