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

Theravance Biopharma

Status and phase: Completed; Phase 1

Conditions: Inflammatory Bowel Disease

Treatments: Drug: Itraconazole; Drug: TD-1473

Study type: Interventional

Funder types: Industry

Identifiers

NCT03555617

0174

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

36 participants in 3 patient groups

TD-1473 formulation bridging & food effect

Experimental group

Description:

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.

Treatment:

Drug: TD-1473

TD-1473 with Itraconazole

Experimental group

Description:

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.

Treatment:

Drug: TD-1473

Drug: Itraconazole

TD-1473 without Itraconazole

Experimental group

Description:

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.

Treatment:

Drug: TD-1473