---
title: Multiple Dose Ethnobridging PK Study in Healthy Subjects
nct_id: NCT03750565
overall_status: COMPLETED
phase: PHASE1
sponsor: Theravance Biopharma
study_type: INTERVENTIONAL
primary_condition: Inflammatory Bowel Diseases
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03750565.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03750565"
ct_last_update_post_date: 2021-01-14
last_seen_at: "2026-05-12T07:18:19.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Multiple Dose Ethnobridging PK Study in Healthy Subjects

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

**NCT ID:** [NCT03750565](https://clinicaltrials.gov/study/NCT03750565)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Theravance Biopharma
- **Conditions:** Inflammatory Bowel Diseases, IBD
- **Start Date:** 2018-11-27
- **Completion Date:** 2019-02-13
- **CT.gov Last Update:** 2021-01-14

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

For All subjects:

* Male or female between 18 to 55 years old
* Female subjects must have documentation of a negative serum pregnancy test,
* Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly efficient birth control method
* Male subjects must be vasectomized with documented medical assessment of the surgical success, or use acceptable contraception
* All male subjects must agree to refrain from sperm donation during the study and for at least 7 days after the last dose of study drug.
* Body Mass Index (BMI) 18 to 32 kg/m2, inclusive, and weighs at least 50 kg and less than 90 kg
* Willing and able to give informed consent
* Additional inclusion criteria apply

For Japanese subjects only:

* Subject must have been born in Japan, with 2 Japanese biological parents and 4 Japanese grandparents as confirmed by interview.
* Subject has lived no longer than 10 years outside of Japan.
* Subject had no significant change in lifestyle, including diet, since leaving Japan.

For Caucasian subjects only:

* Subject has 2 Caucasian biological parents and 4 Caucasian grandparents as confirmed by interview.
* Subject has lived no longer than 10 years outside of Europe and/or North America.

Exclusion Criteria:

For all subjects:

* Subject is a female who is pregnant, lactating, breastfeeding, or planning to become pregnant during the study or within 7 days after the last dose of study drug.
* Subject is a male who is planning to father a child during the study or within 7 days after the last dose of study drug.
* Is positive for hepatitis A, B or C, and/or HIV
* Has clinically significant abnormalities in baseline laboratory evaluations
* Subject has a clinically significant abnormal electrocardiogram (ECG)
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device) Additional exclusion criteria apply
```

## Arms

- **Cohort 1** (EXPERIMENTAL) — Japanese subjects will receive oral doses of either TD-1473 - Dose A or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
- **Cohort 2** (EXPERIMENTAL) — Japanese subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
- **Cohort 3** (EXPERIMENTAL) — Caucasian subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Caucasian subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
- **Cohort 4** (EXPERIMENTAL) — Japanese subjects will receive oral doses of either TD-1473 - Dose C or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.

## Interventions

- **TD-1473 - Dose A** (DRUG) — oral capsule/tablet, QD
- **TD-1473 - Dose B** (DRUG) — oral capsule/tablet, QD
- **TD-1473 - Dose C** (DRUG) — oral capsule/tablet, QD
- **Placebo** (DRUG) — oral capsule/tablet, QD

## Primary Outcomes

- **Area under the concentration-time curve (AUC0 t)** _(time frame: Day 1 & Day 14)_
- **Area under the concentration-time curve (AUC0 24)** _(time frame: Day 1 & Day 14)_
- **Area under the concentration-time curve (AUCtau)** _(time frame: Day 1 & Day 14)_
- **Maximum observed concentration (Cmax)** _(time frame: Day 1 & Day 14)_
- **Maximum observed concentration at steady state (Cmax_ss)** _(time frame: Day 1 & Day 14)_

## Locations (1)

- Theravance Biopharma Investigational Site, Cypress, California, United States

## Recent Field Changes (last 30 days)

- `eligibility.criteria` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.theravance biopharma investigational site|cypress|california|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03750565*  
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