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Evaluation of PK and Safety of D-0120 and Allopurinol

Sponsor
InventisBio Co., Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05360628
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
8.7
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: D-0120 in combination with Allopurinol
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
D0120 AllopurinolD0120 Allopurinol
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Phase I, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic Interactions Between D-0120 and Allopurinol in Healthy Adult Subjects
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Feb 10, 2022
Anticipated Study Completion Date :
Jul 23, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Type, incidence, severity and attribution of AEs. [14 days]

    Evaluation of safety between D-0120 and Allopurinol

  2. Plasma concentration of D-0120 and Allopurinol [14 days]

    Evaluation of exposure between D-0120 and Allopurinol

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Spaulding Clinical West Bend Wisconsin United States 53095

Sponsors and Collaborators

  • InventisBio Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
InventisBio Co., Ltd
ClinicalTrials.gov Identifier:
NCT05360628
Other Study ID Numbers:
  • D0120-104
First Posted:
May 4, 2022
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Allopurinol

Study Results

No Results Posted as of May 6, 2022