Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects

Bowel Diseases, Inflammatory Clinical Trial

Official title: A Phase 1, Two-Part, Open-Label Study to Assess the Relative Bioavailability of Two TD-1473 Tablet Formulations Under Fasted and Fed Conditions in Healthy Subjects and the Pharmacokinetics of TD-1473 in Healthy Chinese Subjects

Status Completed

Clinical Trial Summary

This is a Phase 1, 2-part, open-label study. Part A will be a formulation bridging and food effect study in healthy adult subjects. Part B will be an assessment of pharmacokinetics (PK) in healthy adult Chinese subjects.

Clinical Trial Description

In study Part A, healthy adult subjects will receive the following treatments in a cross-over design with a ≥10-day washout period between doses:

• Treatment A: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state;

• Treatment B: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fed state;

• Treatment C: Single dose of [Tablet B] TD-1473 current clinical tablet formulation on Day 1 in a fasted state;

• Treatment D: Single dose of [Tablet B] TD-1473 current clinical tablet formulation on Day 1 in a fed state.

In study Part B, healthy adult Chinese subjects will receive Treatment A: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state. ;

Related Conditions & MeSH terms

• Bowel Diseases, Inflammatory
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Intestinal Disorder

• NCT number: NCT04587713
• Study type: Interventional
• Source: Theravance Biopharma
• Status: Completed
• Phase: Phase 1
• Start date: October 16, 2020
• Completion date: December 27, 2020