Food-effect, Drug-Drug Interaction (DDI), and Formulation Bridging Study
- Registration Number
- NCT03555617
- Lead Sponsor
- Theravance Biopharma
- Brief Summary
This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TD-1473 formulation bridging & food effect TD-1473 Subjects will receive, on Day 1 of each period, a single 100 mg oral dose of the tablet formulation of TD-1473 in the fed or fasted state, or the PIC formulation of TD-1473 in the fasted state, as part of a 3-period, crossover design. TD-1473 without Itraconazole TD-1473 Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. TD-1473 with Itraconazole TD-1473 Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. In Period 2, subjects will receive, in the fasted state, single oral doses of 200 mg itraconazole solution on Days -4 through 7 for a total of 11 days, with a single 100 mg oral dose of the tablet formulation of TD-1473 co-administered on Day 1. TD-1473 with Itraconazole Itraconazole Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. In Period 2, subjects will receive, in the fasted state, single oral doses of 200 mg itraconazole solution on Days -4 through 7 for a total of 11 days, with a single 100 mg oral dose of the tablet formulation of TD-1473 co-administered on Day 1.
- Primary Outcome Measures
Name Time Method Apparent clearance (Cl/F) in Plasma Up to 8 days post-dose Time to maximum observed concentration (tmax) in Plasma Up to 8 days post-dose Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma Up to 8 days post-dose Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma Up to 8 days post-dose Apparent volume of distribution (Vz/F) in Plasma Up to 8 days post-dose Maximum observed concentration (Cmax) in Plasma Up to 8 days post-dose Apparent terminal elimination half-life (t1/2) in Plasma Up to 8 days post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Celerion
🇺🇸Lincoln, Nebraska, United States