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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-13

Study Completion Date

2018-07-15

Brief Summary

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

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Detailed Description

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Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TD-1473

Intervention Type DRUG

oral capsule/tablet, QD

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.

Group Type EXPERIMENTAL

TD-1473

Intervention Type DRUG

oral capsule/tablet, QD

Itraconazole

Intervention Type DRUG

oral solution, QD

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.

Group Type EXPERIMENTAL

TD-1473

Intervention Type DRUG

oral capsule/tablet, QD

Interventions

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TD-1473

oral capsule/tablet, QD

Intervention Type DRUG

Itraconazole

oral solution, QD

Intervention Type DRUG

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

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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes