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Drug-Drug Interaction Study to Evaluate the Pharmacokinetics and Safety of CTX 4430 and Midazolam

NCT02233244 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-10-10

No results posted yet for this study

Summary

This drug-drug interaction study will assess the potential of CTX-4430 to induce CYP3A activity in healthy subjects.

The study hypothesis is that midazolam (a sensitive, widely used CYP3A4 substrate) blood levels will not change after treatment with CTX-4430.

Conditions

  • Healthy

Interventions

DRUG

CTX-4430

DRUG

Midazolam

Sponsors & Collaborators

  • Celtaxsys, Inc.

    lead OTHER

Principal Investigators

  • Johnston Stewart, MB, BSc · Celerion Belfast, Northern Ireland

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United Kingdom

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 NCT02233244 on ClinicalTrials.gov