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

Primary Purpose

Inflammatory Bowel Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

TD-1473

Itraconazole

About this trial

This is an interventional basic science trial for Inflammatory Bowel Disease focused on measuring healthy volunteers, drug-drug interaction, itraconazole, CYP3A, P-gp, Inflammatory Bowel Disease, IBD, Irritable Bowel Syndrome, IBS

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Celerion

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

TD-1473 formulation bridging & food effect

TD-1473 with Itraconazole

TD-1473 without Itraconazole

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Maximum observed concentration (Cmax) in Plasma

Time to maximum observed concentration (tmax) in Plasma

Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma

Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma

Apparent terminal elimination half-life (t1/2) in Plasma

Apparent clearance (Cl/F) in Plasma

Apparent volume of distribution (Vz/F) in Plasma

Secondary Outcome Measures

Full Information

NCT ID

NCT03555617

First Posted

June 1, 2018

Last Updated

January 12, 2021

Sponsor

Theravance Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT03555617

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

June 13, 2018 (Actual)

Primary Completion Date

July 15, 2018 (Actual)

Study Completion Date

July 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theravance Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Disease

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TD-1473 formulation bridging & food effect

Arm Type

Experimental

Arm Description

Arm Title

TD-1473 with Itraconazole

Arm Type

Experimental

Arm Description

Arm Title

TD-1473 without Itraconazole

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

TD-1473

Intervention Description

oral capsule/tablet, QD

Intervention Type

Drug

Intervention Name(s)

Itraconazole

Intervention Description

oral solution, QD

Primary Outcome Measure Information:

Title

Maximum observed concentration (Cmax) in Plasma

Time Frame

Up to 8 days post-dose

Title

Time to maximum observed concentration (tmax) in Plasma

Time Frame

Up to 8 days post-dose

Title

Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma

Time Frame

Up to 8 days post-dose

Title

Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma

Time Frame

Up to 8 days post-dose

Title

Apparent terminal elimination half-life (t1/2) in Plasma

Time Frame

Up to 8 days post-dose

Title

Apparent clearance (Cl/F) in Plasma

Time Frame

Up to 8 days post-dose

Title

Apparent volume of distribution (Vz/F) in Plasma

Time Frame

Up to 8 days post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Theravance Biopharma

Official's Role

Study Director

Facility Information:

Facility Name

Celerion

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68502

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Learn more about this trial

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

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