NCT03750565

Multiple Dose Ethnobridging PK Study in Healthy Subjects

A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Adult Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects.

Conditions

• Inflammatory Bowel Diseases
• IBD

Interventions

Type	Name	Description
DRUG	TD-1473 - Dose A	oral capsule/tablet, QD
DRUG	TD-1473 - Dose B	oral capsule/tablet, QD
DRUG	TD-1473 - Dose C	oral capsule/tablet, QD
DRUG	Placebo	oral capsule/tablet, QD

Timeline

• Start date: 2018-11-27
• Primary completion: 2019-02-13
• Completion: 2019-02-13
• First posted: 2018-11-23
• Last updated: 2021-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study