Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

NCT01698333 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-10-24

Study results available
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Summary

Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is designed to determine the adrenal effects of the investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of the formulation.

Conditions

Interventions

DRUG

122-0551

Applied twice daily for 2 weeks

Sponsors & Collaborators

  • Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Syd Dromgoole, PhD · Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-03-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Entities

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 NCT01698333 on ClinicalTrials.gov