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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03555617

Enrollment

Registered

2018-06-13

Start date

2018-06-13

Completion date

2018-07-15

Last updated

2021-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease

Keywords

healthy volunteers, drug-drug interaction, itraconazole, CYP3A, P-gp, Inflammatory Bowel Disease, IBD, Irritable Bowel Syndrome, IBS

Brief summary

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

Interventions

DRUGTD-1473

oral capsule/tablet, QD

DRUGItraconazole

oral solution, QD

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

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

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026