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

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

Official Title
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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

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: TD-1473
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-1473 formulation bridging & food effect<br>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<br>* oral capsule/tablet, QD<br>|
| Experimental: TD-1473 with Itraconazole<br>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<br>* oral capsule/tablet, QD<br>Drug: Itraconazole<br>* oral solution, QD<br>|
| Experimental: TD-1473 without Itraconazole<br>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<br>* oral capsule/tablet, QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, healthy volunteers, drug-drug interaction, itraconazole, CYP3A, P-gp, Inflammatory Bowel Disease, IBD, Irritable Bowel Syndrome