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

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555617
• Other study ID #: 0174
• Status: Completed
• Phase: Phase 1
• Start date: June 13, 2018
• Est. completion date: July 15, 2018

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• TD-1473
oral capsule/tablet, QD
• Itraconazole
oral solution, QD

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed concentration (Cmax) in Plasma		Up to 8 days post-dose
Primary	Time to maximum observed concentration (tmax) in Plasma		Up to 8 days post-dose
Primary	Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma		Up to 8 days post-dose
Primary	Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma		Up to 8 days post-dose
Primary	Apparent terminal elimination half-life (t1/2) in Plasma		Up to 8 days post-dose
Primary	Apparent clearance (Cl/F) in Plasma		Up to 8 days post-dose
Primary	Apparent volume of distribution (Vz/F) in Plasma		Up to 8 days post-dose