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Open-label, Single Center, Non-randomized, Fixed Sequence Phase 1 Drug-drug Interaction Study With LEO 32731 and Midazolam

NCT03126578 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-11-14

No results posted yet for this study

Summary

This is a single center, non-randomized, open-label, fixed sequence study to investigate the effect of multiple oral dosing of LEO 32731 (up-titrated), on CYP3A activity in healthy male subjects using midazolam as a probe CYP3A substrate.

The study will be conducted in two seamless parts:

Part I - Maximal Tolerated Dose (MTD) Part II - Drug-Drug Interaction with midazolam

Conditions

  • Drug Interaction Potentiation

Interventions

DRUG

LEO 32731

LEO 32731 is being developed by LEO Pharma.

DRUG

Midazolam

Benzodiazepine

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Manuela Koch, MD · Nuvisan GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2017-10-20
Completion
2017-10-20

Countries

  • Germany

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 NCT03126578 on ClinicalTrials.gov