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Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects

NCT04587713 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-04-09

No results posted yet for this study

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.

Conditions

  • Intestinal Disorder
  • Bowel Diseases, Inflammatory

Interventions

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

Sponsors & Collaborators

  • Theravance Biopharma

    lead INDUSTRY

Principal Investigators

  • Study Director · Theravance Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-16
Primary Completion
2020-12-24
Completion
2020-12-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04587713 on ClinicalTrials.gov