Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-08 @ 8:42 AM
Study NCT ID:
NCT03024034
Status:
COMPLETED
Last Update Posted:
2021-12-13
First Post:
2017-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 TP-271 Oral PK Single Ascending Dose Study
Sponsor:
Tetraphase Pharmaceuticals, Inc
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TP-271 in Healthy Adult Subjects, Including 1 Cross-over Arm
Status:
COMPLETED
Status Verified Date:
2021-12
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 determine the safety and tolerability of up to 6 different single ascending oral doses of TP-271, ranging from 25 mg to 300 mg, in healthy adult male or female subjects.
Detailed Description:
This study is designed to assess oral TP-271, and the objectives of the study are to examine the safety, tolerability, and PK of oral TP-271 in healthy adult subjects after administration of a single dose. A single-dose, dose-escalating study design is common for early clinical studies. A cohort size of 8 subjects (6 receiving oral TP-271 and 2 receiving placebo) for the single ascending dose cohorts (Cohorts A through F) will allow sufficient data assessments of plasma and urine concentrations, plasma PK parameters, and safety without exposing large numbers of subjects to oral TP-271 in this clinical study. One additional cohort of 8 subjects will first receive treatment with TP-271 or TP-271 co-administered with ethylenediaminetetraacetic acid (EDTA) and then cross-over to treatment with the other study agent, which will allow a comparison of the bioavailability of TP-271 alone compared to TP-271 co-administered with EDTA, as well as allow additional assessment of plasma and urine concentrations, plasma PK parameters, and safety.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 15-0061 | OTHER | NIAID | View |