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Multiple Dose Ethnobridging PK Study in Healthy Subjects

NCT03750565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-01-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Theravance Biopharma

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2019-02-13
Completion
2019-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03750565 on ClinicalTrials.gov