Evaluation of PK and Safety of D-0120 and Allopurinol

February 27, 2023 updated by: InventisBio Co., Ltd

A Phase I, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic Interactions Between D-0120 and Allopurinol in Healthy Adult Subjects

Evaluation of safety and PK interaction between D-0120 and Alopurinol in healthy adult subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • West Bend, Wisconsin, United States, 53095
        • Spaulding Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects between the ages of 18-55
  • Required evaluation by Investigator for screening and enrollment
  • Agreement and compliance with the study and follow-up procedures

Exclusion Criteria:

  • Significant medical history or current comorbidly determined by the Investigator.
  • Pregnant or nursing women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D-0120 plus Allopurinol
D-0120 dosing followed by Allopurinol and combination treatment
Drug: D-0120 in combination with Allopurinol
noted above
Experimental: Allopurinol plus D-0120
Allopurinol dosing followed by D-0120 and combination treatment
Drug: D-0120 in combination with Allopurinol
noted above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type, incidence, severity and attribution of AEs.
Time Frame: 14 days
Evaluation of safety between D-0120 and Allopurinol
14 days
Plasma concentration of D-0120 and Allopurinol
Time Frame: 14 days
Evaluation of exposure between D-0120 and Allopurinol
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InventisBio Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

February 10, 2022

Study Completion (Actual)

July 23, 2022

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0120-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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