GoutPhase 1NCT04303039
Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects
A Phase 1 study testing ABP-671 in people with Gout and Food-drug Interaction, run by Atom Therapeutics Co., Ltd at 1 site in United States.
Trial summary
This is a single center, open-label, single-dose, 2-way randomized crossover design in which 12 healthy subjects will be randomized to 1 of 2 treatment sequences (AB or BA). Treatments A and B will consist of single oral dose of tablet formulation (1.0 mg as 1 x 1.0 mg) in the fasted and fed state administered with… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout, Food-drug Interaction
- What is being tested?
- ABP-671
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2020to 19 Jun 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 to 60 years, inclusive
- Healthy
- Subjects must have the serum uric acid level at screening ≥ 3.7 mg/dL to ≤ 7.0 mg/dL for males, and ≥ 2.3 mg/dL to ≤ 6.0 mg/dL for females.
- Subjects must have a Body Mass Index (BMI) between 18 and 35 kg/m2 at screening (inclusive).
- Subjects must have a body weight of 50 kg or higher.
- Females must be non-pregnant and non-lactating
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- Males must be surgically sterile, abstinent, or if engaged in sexual relations with a female partner of child-bearing potential, be using a condom with spermicide
- Subjects must have a CBC and platelet count within normal range
- Subjects must have normal blood chemistry
- Subjects must have a normal urinalysis
- Subjects meeting inclusion and exclusion criteria must have a renal ultrasound determined to be normal or non-clinically significant
- Subjects must have a normal estimated glomerular filtration rate
- Subjects must have a normal ECG
- Subjects must be able to comply with the study and follow-up procedures
- Subjects are able to understand the study procedures and risks involved and must provided signed informed consent to participate in the study
Who cannot join
- Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, including latent tuberculosis, cardiovascular, gastrointestinal including cholecystectomy, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Subjects with prior history of bariatric surgery, intestinal resection, malabsorption, or celiac disease with an exception of subjects with appendectomy.
- Subjects who have any history or suspicion of kidney stones or evidence of renal stones or opacification with renal ultrasound prior to dosing on Day -1.
- Subjects who have any history of gout.
- Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen, and/or Hepatitis C virus.
- Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days screening period before Day 1 of study medication dosing. Females who have received hormone replacement therapy (HRT) within 14 days prior to dosing.
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- Subjects who are positive for urine drug screening tests.
- Subjects who have undergone major surgery within 3 months prior to Day 1.
- Women who are pregnant or breastfeeding.
- Subjects who received any investigational test article within 5 half-lives or 30 days, whichever is longer, prior to Day 1 study medication dosing.
- Subjects who previously received ABP-671.
- Recent blood donation for more than 500 mL within 2 months of screening.
- Subjects who consumed Seville oranges- or grapefruit-containing foods or beverages within 7 days before Day 1 and during the entire study duration.
- Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Investigate the Effects of Food on the Relative Bioavailability of a Tablet Formulation of ABP-671 in Healthy Subjects
This is a single center, open-label, single-dose, 2-way randomized crossover design in which 12 healthy subjects will be randomized to 1 of 2 treatment sequences (AB or BA). Treatments A and B will consist of single oral dose of tablet formulation (1.0 mg as 1 x 1.0 mg) in the fasted and fed state administered with approximately 240 mL of water. Each period will be separated by a washout interval of 4 days.
- Conditions
- Gout, Food-drug Interaction
- Being tested
- ABP-671
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP-671Drug
ABP-671 Tablet 1.0 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Single 1.0 mg dose of ABP-671 in the fasted state. Receives: Drug: ABP-671 |
| Treatment B | Experimental | Single 1.0 mg dose of ABP-671 in the fed state, after a standardized breakfast. Receives: Drug: ABP-671 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma ABP-671 Concentration
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
Measured: 72 hours
Secondary outcomes (4)
Serum Uric Acid Concentration
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
Measured: 72 hours
Serum Creatinine Concentration
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
Measured: 72 hours
Urine Uric Acid Concentration
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
Measured: 72 hours
Urine Creatinine Concentration
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start22 May 2020
- Primary completion9 Jun 2020
- Study completion19 Jun 2020
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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atom Therapeutics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303039
- Sponsor's protocol ID
- ABP-671-103
- Status last verified
- Jun 2020
- First submitted
- 6 Mar 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Investigate the Effects of Food on the Relative Bioavailability of a Tablet Formulation of ABP-671 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04303039
- Acronym / sponsor ID
- ABP-671-103
- Conditions
- Gout, Food-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Atom Therapeutics Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 May 2020 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 19 Jun 2020 (actual)
- First posted
- 10 Mar 2020 (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.
This is a single center, open-label, single-dose, 2-way randomized crossover design in which 12 healthy subjects will be randomized to 1 of 2 treatment sequences (AB or BA). Treatments A and B will consist of single oral dose of tablet formulation (1.0 mg as 1 x 1.0 mg) in the fasted and fed state administered with approximately 240 mL of water. Each period will be separated by a washout interval of 4 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: ABP-671Single 1.0 mg dose of ABP-671 in the fasted state. |
| Treatment B | Experimental | Drug: ABP-671Single 1.0 mg dose of ABP-671 in the fed state, after a standardized breakfast. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male or female aged 18 to 60 years, inclusive
- Healthy
- Subjects must have the serum uric acid level at screening ≥ 3.7 mg/dL to ≤ 7.0 mg/dL for males, and ≥ 2.3 mg/dL to ≤ 6.0 mg/dL for females.
- Subjects must have a Body Mass Index (BMI) between 18 and 35 kg/m2 at screening (inclusive).
- Subjects must have a body weight of 50 kg or higher.
Key exclusion criteria (14 listed)
- Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, including latent tuberculosis, cardiovascular, gastrointestinal including cholecystectomy, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Subjects with prior history of bariatric surgery, intestinal resection, malabsorption, or celiac disease with an exception of subjects with appendectomy.
- Subjects who have any history or suspicion of kidney stones or evidence of renal stones or opacification with renal ultrasound prior to dosing on Day -1.
- Subjects who have any history of gout.
- Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen, and/or Hepatitis C virus.
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 |
|---|---|---|
| ABP-671ABP-671 Tablet 1.0 mg | Drug | Treatment A, Treatment B |
Primary outcome
Plasma ABP-671 Concentration
Time frame: 72 hours
At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.
4 secondary outcomes
Serum Uric Acid Concentration
Time frame: 72 hours
Serum Creatinine Concentration
Time frame: 72 hours
Urine Uric Acid Concentration
Time frame: 72 hours
Urine Creatinine Concentration
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 ABP-671 in people with Gout and Food-drug Interaction, run by Atom Therapeutics Co., Ltd at 1 site in United States.
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 15 inclusion and 14 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: finished, as of the sponsor's last update on 23 Jun 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma ABP-671 Concentration (time frame: 72 hours). 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 23 Jun 2020.