NCT04587713

Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Intestinal Disorder
• Bowel Diseases, Inflammatory

Interventions

Type	Name	Description
DRUG	TD-1473 [Tablet A]	TD-1473 \[Tablet A\] (1 Tablet = Dose A) proposed commercial tablet formulation
DRUG	TD-1473 [Tablet B]	TD-1473 \[Tablet B\] (2 Tablets = Dose A) current clinical tablet formulation

Timeline

• Start date: 2020-10-16
• Primary completion: 2020-12-24
• Completion: 2020-12-27
• First posted: 2020-10-14
• Last updated: 2021-04-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study