NCT05360628

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1 healthy

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

November 1, 2021

Last Update Submit

February 27, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Type, incidence, severity and attribution of AEs.

    Evaluation of safety between D-0120 and Allopurinol

    14 days

  • Plasma concentration of D-0120 and Allopurinol

    Evaluation of exposure between D-0120 and Allopurinol

    14 days

Study Arms (2)

D-0120 plus Allopurinol

EXPERIMENTAL

D-0120 dosing followed by Allopurinol and combination treatment

Drug: D-0120 in combination with Allopurinol

Allopurinol plus D-0120

EXPERIMENTAL

Allopurinol dosing followed by D-0120 and combination treatment

Drug: D-0120 in combination with Allopurinol

Interventions

D-0120 in combination with AllopurinolDRUG

noted above

Allopurinol plus D-0120D-0120 plus Allopurinol

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

Location

MeSH Terms

Interventions

Allopurinol

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: D0120 Allopurinol
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2021

First Posted

May 4, 2022

Study Start

November 1, 2021

Primary Completion

February 10, 2022

Study Completion

July 23, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)