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Completed Phase 1 Interventional Accepts healthy volunteers

Study of Single-dose DS-3201b in Participants With Hepatic Impairment

ClinicalTrials.gov ID: NCT04276662

Public ClinicalTrials.gov record NCT04276662. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 29, 2026, 12:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label, Single-dose Study to Assess the Pharmacokinetics of DS-3201b In Subjects With Hepatic Impairment

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 1, open-label, parallel design, single-dose pharmacokinetic (PK) study to assess the safety, tolerability, and PK of a single dose of 50 mg of DS-3201b in participants with normal and impaired hepatic function.

Study identification

NCT ID
NCT04276662
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
28 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 21, 2019 (Actual)
Primary completion
Feb 23, 2021 (Actual)
Completion
Feb 23, 2021 (Actual)
Last update posted
Feb 25, 2021

2019 – 2021

United States locations

U.S. sites
3
U.S. states
2
U.S. cities
3
Facility City State ZIP Site status
Clinical Pharmacology of Miami, LLC Miami Florida 33014 —
Orlando Clinical Research Center Orlando Florida 32809 —
Worldwide Clinical Trials San Antonio Texas 78217 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04276662, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 25, 2021 · Synced Oct 29, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04276662 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →