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Drug Interaction Study of Levoketoconazole and Metformin

NCT03880825 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-08-30

No results posted yet for this study

Summary

This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects.

Conditions

  • Healthy Subjects

Interventions

DRUG

Metformin 500 mg Oral Tablet

single dose

DRUG

Levoketoconazole 150 - 600 mg (BID)

escalating dose from 150 mg to 600 mg (BID)

Sponsors & Collaborators

  • Cortendo AB

    lead INDUSTRY

Principal Investigators

  • Steven Schoenfeld, MD · Cortendo AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2019-05-03
Completion
2019-05-03
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 NCT03880825 on ClinicalTrials.gov