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Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers

NCT03301298 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-09-26

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

SXC-2023

Oral capsule

DRUG

Placebo oral capsule

Placebo given as oral capsule.

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Promentis Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Tricia Cotter · Promentis Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-11
Primary Completion
2018-02-13
Completion
2018-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03301298 on ClinicalTrials.gov