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A Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Debio 1450 in Healthy Subjects

NCT ID: NCT03209648

Last Updated: 2017-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-14

Study Completion Date

2017-08-31

Brief Summary

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Debio 1450 is metabolised mainly by CYP3A4, therefore inhibitors of CYP3A4 have the potential to raise Debio 1450 plasma concentrations. Hence, it is important to determine the effect of CYP3A4 inhibition by itraconazole on the Pharmacokinetics of Debio 1450.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Debio 1450

In Treatment Period 1, participants will receive single oral dose of Debio 1450 40 mg on Day 1. In Treatment Period 2, participants will receive itraconazole 200 mg, twice daily (BID) orally, on Day 1, followed by itraconazole 200 mg once daily (QD), on Days 2 to 4, and then single oral dose of Debio 1450 40 mg and itraconazole 200 mg on Day 5, followed by a single oral dose of itraconazole 200 mg on Days 6 and 7.

Group Type EXPERIMENTAL

Debio 1450

Intervention Type DRUG

Debio 1450, 40 mg capsule.

Itraconazole

Intervention Type DRUG

Itraconazole, 20 mL of 10 mg/mL solution.

Interventions

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Debio 1450

Debio 1450, 40 mg capsule.

Intervention Type DRUG

Itraconazole

Itraconazole, 20 mL of 10 mg/mL solution.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meets protocol-specified criteria for qualification and contraception.
* Is willing and able to comply with restrictions related to food, drink and medications.
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures.

Exclusion Criteria

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters.
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

* the safety or well-being of the participant or study staff.
* the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); the analysis of results.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Debiopharm International SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Covance Clinical Research Unit Ltd.

Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2017-001352-60

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Debio 1450-111

Identifier Type: -

Identifier Source: org_study_id