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

Sponsor

Theravance Biopharma (Industry)

Overall Status

Completed

CT.gov ID

NCT03555617

Collaborator

(none)

Enrollment

Location

Arms

1.1

Actual Duration (Months)

34.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease	Drug: TD-1473 Drug: Itraconazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase 1, Open-Label, 2-Cohort Study to Assess the Single Dose Pharmacokinetics of Two Formulations of TD-1473 and to Assess the Effect of a High-Fat Meal and Itraconazole on the Pharmacokinetics of TD-1473 in Healthy Subjects

Actual Study Start Date :

Jun 13, 2018

Actual Primary Completion Date :

Jul 15, 2018

Actual Study Completion Date :

Jul 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TD-1473 formulation bridging & food effect 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.	Drug: TD-1473 oral capsule/tablet, QD
Experimental: TD-1473 with 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.	Drug: TD-1473 oral capsule/tablet, QD Drug: Itraconazole oral solution, QD
Experimental: TD-1473 without 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.	Drug: TD-1473 oral capsule/tablet, QD

Arm

Intervention/Treatment

Experimental: TD-1473 formulation bridging & food effect

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.

Drug: TD-1473

oral capsule/tablet, QD

Experimental: TD-1473 with 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.

Drug: TD-1473

oral capsule/tablet, QD

Drug: Itraconazole

oral solution, QD

Experimental: TD-1473 without 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.

Drug: TD-1473

oral capsule/tablet, QD

Outcome Measures

Primary Outcome Measures

Maximum observed concentration (Cmax) 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 terminal elimination half-life (t1/2) in Plasma [Up to 8 days post-dose]
Apparent clearance (Cl/F) in Plasma [Up to 8 days post-dose]
Apparent volume of distribution (Vz/F) in Plasma [Up to 8 days post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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