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

• Status: Completed
• Trial end date: 2017-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Debiopharm International SA
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

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.