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

NCT03555617 | Completed Phase 1 FDA Drug

• 1 other identifier: 0174
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammatory Bowel Disease

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (3)

TD-1473 formulation bridging & food effect

EXPERIMENTAL

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

TD-1473 with Itraconazole

EXPERIMENTAL

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; Drug: Itraconazole

TD-1473 without Itraconazole

EXPERIMENTAL

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

Interventions

TD-1473 DRUG

oral capsule/tablet, QD

TD-1473 formulation bridging & food effect; TD-1473 with Itraconazole; TD-1473 without Itraconazole

Itraconazole DRUG

oral solution, QD

TD-1473 with Itraconazole

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Irritable Bowel Syndrome

Interventions

izencitinib; Itraconazole

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 13, 2018
• Study Start: June 13, 2018
• Primary Completion: July 15, 2018
• Study Completion: July 15, 2018
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)