CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
SXC-2023 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03301298
NCT03301298Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Food Effect of SXC-2023 When Administered Orally to Healthy Adult Subjects

Promentis Pharmaceuticals, Inc.·interventional·Posted Oct 4, 2017·Updated Sep 26, 2019

In Brief

A Phase 1 clinical trial evaluating SXC-2023 and Placebo oral capsule for Healthy. Completed, enrolled 48 participants across 1 site.

Detailed Summary

This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsCelerion

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 4, 2017
Enrollment StartSep 11, 2017
Primary CompletionFeb 13, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.7 years ago

Interventions

SXC-2023drug

Oral capsule

Placebo oral capsuledrug

Placebo given as oral capsule.