GoutPhase 1NCT05324423
To Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout
A Phase 1 study testing Colchicine in people with Gout, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gout
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2021to 1 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a body mass index ≥18.0 and ≤32 kg/m2;
- Screening sUA value ≥480μmol/L;
- Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Who cannot join
- Subject known or suspected of being sensitive to the study drugs or its ingredient；sCr>ULN；
- History of kidney stones or screening kidney stones by B-ultrasound;
- History of malignancy；
- History of xanthinuria；
- Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood
- ALT or AST > 1.5 x ULN
Show all 10Show fewer
- Unstable angina, history of symptomatic arrhythmia, or heart failure
- HbAlc>8%
- eGFR<60ml/min/1.73m2
- Investigational drug within 3 months of study dosing
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Yu Cao, Doctor, 18661809090, caoyu1767@126.com
About this study
Official title: A Single-center, Open-access Study to Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout
A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout
- Conditions
- Gout
- Being tested
- Colchicine
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Febuxostat、XNW3009
Colchicine0.5 mg Oral Tablet Day-7~Day25 qd；Febuxostat 40 mg Oral Tablet Day1 and Day14 qd；XNW3009 0.5 mg Oral Tablet Day8 and Day21 qd
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Colchicine 0.5 mg Oral Tablet Day-7~Day25 qd, Febuxostat 40 mg Oral Tablet Day1 and Day14 qd, XNW3009 0.5 mg Oral Tablet Day8~Day21 qd.
Interventions:
Drug: Colchicine Drug: Febuxostat Drug: XNW3009 Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed maximum concentration at steady state (Cmax,ss)
To evaluate the maximum concentration at steady state of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout
Measured: 100 days
Observed area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
To evaluate the AUCss of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout
Measured: 100 days
Secondary outcomes (6)
Time to Maximum Serum Concentration (Tmax)
To evaluate the Tmax of oral XNW3009 tablets, febuxostat and colchicine in patients with gout
Measured: 100 days
Mean Terminal Phase Half-life (t1/2)
To evaluate the t1/2 of XNW3009 tablets, febuxostat and colchicine in gout patients
Measured: 100 days
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Measured: 100 days
Serum or urine Uric Acid Level
Change in Serum or urine Uric Acid Level
Measured: 100 days
Serum or urine Creatinine
Change in Serum or urine Creatinine
Measured: 100 days
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Investigator judged clinical significance of laboratory test abnormalities.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start18 Oct 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Xu, Doctor, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324423
- Sponsor's protocol ID
- XNW3009-I-04
- Status last verified
- May 2022
- First submitted
- 12 Dec 2021
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-access Study to Evaluate Drug Interactions Between XNW3009, Febuxostat, and Colchicine in Patients With Gout
- ClinicalTrials.gov ID
- NCT05324423
- Acronym / sponsor ID
- XNW3009-I-04
- Conditions
- Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center, open-access study to evaluate drug interactions between XNW3009, febuxostat, and colchicine in patients with gout
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: ColchicineColchicine 0.5 mg Oral Tablet Day-7~Day25 qd, Febuxostat 40 mg Oral Tablet Day1 and Day14 qd, XNW3009 0.5 mg Oral Tablet Day8~Day21 qd. Interventions: Drug: Colchicine Drug: Febuxostat Drug: XNW3009 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has a body mass index ≥18.0 and ≤32 kg/m2;
- Screening sUA value ≥480μmol/L;
- Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Key exclusion criteria (10 listed)
- Subject known or suspected of being sensitive to the study drugs or its ingredient；sCr>ULN；
- History of kidney stones or screening kidney stones by B-ultrasound;
- History of malignancy；
- History of xanthinuria；
- Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineAlso: Febuxostat、XNW3009Colchicine0.5 mg Oral Tablet Day-7~Day25 qd；Febuxostat 40 mg Oral Tablet Day1 and Day14 qd；XNW3009 0.5 mg Oral Tablet Day8 and Day21 qd | Drug | Cohort 1 |
Primary outcome
Observed maximum concentration at steady state (Cmax,ss)
Time frame: 100 days
To evaluate the maximum concentration at steady state of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout
Observed area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss)
Time frame: 100 days
To evaluate the AUCss of oral XNW3009 tablets, febuxostat, and colchicine in patients with gout
6 secondary outcomes
Time to Maximum Serum Concentration (Tmax)
Time frame: 100 days
Mean Terminal Phase Half-life (t1/2)
Time frame: 100 days
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)
Time frame: 100 days
Serum or urine Uric Acid Level
Time frame: 100 days
Serum or urine Creatinine
Time frame: 100 days
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Time frame: 100 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Xu, Doctor principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Colchicine in people with Gout, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao, Doctor (18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed maximum concentration at steady state (Cmax,ss) (time frame: 100 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.