ClinicalTrials.gg
CompletedNCT07367971Updated Nov 2, 2026

Drug-Drug Interaction Study of ABP-671 in Gout Patients

A Phase 1 interventional study of ABP-671 plus allopurinol in Gout Chronic, Gout and DDI (Drug-Drug Interaction), sponsored by Atom Therapeutics Co., Ltd. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Atom Therapeutics Co., Ltd · Phase 1, Interventional, and Treatment

Updated Nov 2, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 16 studies testing allopurinol in Gout — 1 open to participants now, 1 under way, none of them phase 3. Allopurinol · Gout.

Enrollment
14th of 16
22 · median 46
Started
2026
the only one that year
Phase 1
2 of 16
none open now
Registered
16th of 16
by date

Among the 16 studies testing allopurinol in Gout, this one is the 14th largest by enrollment, is the only one that started in 2026, is one of 2 in phase 1, and was the 16th registered.

Gout

345 studies on the registry are indexed under Gout; 49 are open to participants now.

Browse Gout studies →

Open to participants now

1 of the 16 studies testing allopurinol in Gout is open now. Recruiting first, the newest first:

About allopurinol

Allopurinol: first FDA approval 1966 (ZYLOPRIM), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 30 Gout studies recruiting now, 14 (47%) set no upper age limit and 10 (33%) stop at 75 or younger; none take children under 18; none take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

This is a open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients. Pharmacokinetic (PK) interaction between ABP-671 and Allopurinol will be evaluated in participants who are on stable Allopurinol therapy.

03

Conditions studied

  • Gout Chronic
  • Gout
  • DDI (Drug-Drug Interaction)

Browse trials for

Keywords

  • gout
  • Gout Chronic
  • ABP-671
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults 18-75 years with clinical diagnosis of gout.
  • Stable Allopurinol therapy QD for ≥14 days prior to Day 1.
  • Cohort N: Normal renal function.
  • Cohort R: Moderate renal impairment.

Exclusion criteria

Exclusion Criteria:

  • hepatic impairment.
  • History of Allopurinol .
  • Pregnancy or breastfeeding.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    ABP-671

    Drug: ABP-671 plus allopurinol

Interventions

  • DrugABP-671 plus allopurinol

    Drug pages: ABP-671 · Allopurinol

    All subjects undergo three sequential 7-day periods: Period 1 (Day 1-7): Allopurinol; Period 2 (Day 1-7): Allopurinol Plus ABP-671; Period 3 (Day 1-7): ABP-671;

06

What researchers measure

Primary outcomes

  1. Maximum plasma concentration (Cmax) of allopurinol

    Maximum observed plasma concentration (Cmax) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state.

    Time frame: Base line, through Day1, Day 7,Day8,D14,D15,D21

  2. Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol

    Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state.

    Time frame: Base line, through Day1, Day 7,Day8,D14,D15,D21

Secondary outcomes

  1. Maximum plasma concentration (Cmax) of ABP-671

    Maximum observed plasma concentration (Cmax) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period.

    Time frame: Though Day7,Day8,Day14,Day15,Day21

  2. Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671

    Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period.

    Time frame: Though Day7,Day8,Day14,Day15,Day21

  3. Incidence of treatment-emergent adverse events (TEAEs)

    Number and percentage of participants experiencing treatment-emergent adverse events.

    Time frame: Through study completion, an average of 51 days

07

Study locations

1 site
  • Wakefield Clinical Research
    Cary, North Carolina 27560, United States
08

References and documents

Individual participant data

Plan to share: No — there is no need at present.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2026 to primary completion in Aug 2026, 6 months.

Of 37 industry-sponsored phase 1 interventional studies under Gout, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 14. This study's 6 months is close to that.

Counting every sponsor, half of 40 studies reached it within 6 months; a quarter within 1 and three quarters within 14.

Primary completion moved once since we started tracking on Sep 25, 2026: Jul 2026 → Aug 2026, on Nov 2, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 27, 2025
First posted
Jan 26, 2026
StartActual
Jan 23, 2026
Primary completionActual
Aug 19, 2026was Jul 2026
CompletionActual
Aug 19, 2026
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 2, 2026
Primary completion
Jul 31, 2026→Aug 19, 2026 (actual)
Nov 2, 2026
Study completion
Aug 31, 2026→Aug 19, 2026 (actual)
Nov 2, 2026
Enrollment
20 (estimated)→22 (actual)
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Recruiting→Completed
    Primary completion Jul 31, 2026→Aug 19, 2026 (now actual)
    Study completion Aug 31, 2026→Aug 19, 2026 (now actual)
    Enrollment 20 (estimated)→22 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07367971
Lead sponsor
Atom Therapeutics Co., Ltd
Responsible party
Sponsor
First posted
Jan 26, 2026
Start date
Jan 23, 2026
Primary completion
Aug 19, 2026
Completion
Aug 19, 2026
Last update
Nov 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: ABP-671 · Allopurinol

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