Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study

• Status: Completed
• Trial end date: 2018-07-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.

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

Details

• Lead Sponsor: Theravance Biopharma
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

Inclusion Criteria:

• Male or female between 18 to 55 years old

• Male subjects must abstain from sexual intercourse or use a highly effective method of birth control

• Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control

• Body Mass Index (BMI) 18 to 32 kg/m2

• Willing and able to give informed consent

• Additional inclusion criteria apply

Exclusion Criteria:

• Planning to conceive a child during the study or within 2 months after the last dose of study drug

• Is positive for hepatitis A, B or C, and/or HIV

• Has clinically significant abnormalities in baseline laboratory evaluations

• Subject has a clinically significant abnormal electrocardiogram (ECG)

• Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device)

• Additional exclusion criteria apply