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

Debiopharm

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Itraconazole; Drug: Debio 1450

Study type: Interventional

Funder types: Industry

Identifiers

NCT03209648

2017-001352-60 (EudraCT Number)

Debio 1450-111

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Debio 1450

Experimental group

Description:

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.

Treatment:

Drug: Itraconazole

Drug: Debio 1450