GoutPhase 1NCT03291782
D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
A Phase 1 study testing D-0120 in people with Gout, run by InventisBio Co., Ltd at 1 site in United States.
Trial summary
This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout
- What is being tested?
- D-0120
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2017to 6 Aug 2018
- 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
- Subjects must be medically documented as healthy and acceptable at physical examination.
- Subjects serum uric acid level at screening ≥ 4.5 mg/dL.
- Subjects must have a BMI between 18.0 and 30.0 kg/m2 and a body weight of 50 kg or higher
- Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator.
- Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator.
- Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.
Who cannot join
- Any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Any history or suspicion of kidney stones.
- Positive for HIV, Hepatitis B, and/or Hepatitis C.
- Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing.
- Undergone major surgery within 3 months prior to Day 1.
- Women who are pregnant or breastfeeding.
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- Subjects who received any investigational test article within 5 half-lives or 30 days prior to Day 1 study medication dosing.
- 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.
United States1 site
Covance Daytona Beach Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, and Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics; Including an Open-label Cohort to Determine the Effect of Food on the Pharmacokinetics of D-0120-NA Tablet in Healthy Volunteers in the United States
This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs).
In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label manner; once in the fasted state and once in the fed state.
- Conditions
- Gout
- Being tested
- D-0120
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-0120Drug
oral, single dose
| Study group | Role | What they receive |
|---|---|---|
| D-0120 Dose 1 | Experimental | D-0120 Dose 1 Patients will get D-0120 single agent or placebo of matching size during dose escalation Receives: Drug: D-0120 |
| D-0120 Dose 2 | Experimental | D-0120 Dose 2 Patients will get D-0120 single agent or placebo of matching size during dose escalation Receives: Drug: D-0120 |
| D-0120 Dose 3 | Experimental | D-0120 Dose 3 Patients will get D-0120 single agent or placebo of matching size during dose escalation Receives: Drug: D-0120 |
| D-0120 Dose 4 | Experimental | D-0120 Dose 4 Patients will get D-0120 single agent or placebo of matching size during dose escalation Receives: Drug: D-0120 |
| D-0120 Dose 5 | Experimental | D-0120 Dose 5 Patients will get D-0120 single agent once in the fasted state and once in the fed state. Receives: Drug: D-0120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs
Measured: 2 weeks
Secondary outcomes (7)
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
AUC: area under the plasma concentration versus time curve for D-0120
Measured: Day-1 through 3
Pharmacokinetic: maximum plasma drug concentration (Cmax)
Cmax: maximum plasma drug concentration of D-0120
Measured: Day-1 through 3
Pharmacokinetic: Time to reach the Cmax (Tmax)
Tmax: Time to reach the Cmax of D-0120
Measured: Day-1 through 3
Pharmacokinetic: Apparent terminal half-life (t1/2)
t1/2: apparent terminal half-life of D-0120
Measured: Day-1 through 3
Pharmacokinetic: Apparent oral clearance (CL/F)
CL/F: Apparent oral clearance of D-0120
Measured: Day-1 through 3
Pharmacokinetic: Apparent volume of distribution (Vz/F)
Vz/F: Apparent volume of distribution of D-0120
Measured: Day-1 through 3
PD profile of D-0120 from plasma and urine
Profile in terms of Serum uric acid and creatinine; Urine uric acid and creatinine. These parameters will be combined to report fractional excretion of uric acid (FEUa %)
Measured: Day-1 through 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start13 Sep 2017
- Primary completion6 Apr 2018
- Study completion6 Aug 2018
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugh Coleman, MD, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291782
- Sponsor's protocol ID
- IBIO-201
- Status last verified
- Jun 2018
- First submitted
- 14 Sep 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, and Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics; Including an Open-label Cohort to Determine the Effect of Food on the Pharmacokinetics of D-0120-NA Tablet in Healthy Volunteers in the United States
- ClinicalTrials.gov ID
- NCT03291782
- Acronym / sponsor ID
- IBIO-201
- Conditions
- Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Aug 2018 (actual)
- First posted
- 25 Sep 2017 (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 initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs).
In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label manner; once in the fasted state and once in the fed state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| D-0120 Dose 1 | Experimental | Drug: D-0120D-0120 Dose 1 Patients will get D-0120 single agent or placebo of matching size during dose escalation |
| D-0120 Dose 2 | Experimental | Drug: D-0120D-0120 Dose 2 Patients will get D-0120 single agent or placebo of matching size during dose escalation |
| D-0120 Dose 3 | Experimental | Drug: D-0120D-0120 Dose 3 Patients will get D-0120 single agent or placebo of matching size during dose escalation |
| D-0120 Dose 4 | Experimental | Drug: D-0120D-0120 Dose 4 Patients will get D-0120 single agent or placebo of matching size during dose escalation |
| D-0120 Dose 5 | Experimental | Drug: D-0120D-0120 Dose 5 Patients will get D-0120 single agent once in the fasted state and once in the fed state. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must be medically documented as healthy and acceptable at physical examination.
- Subjects serum uric acid level at screening ≥ 4.5 mg/dL.
- Subjects must have a BMI between 18.0 and 30.0 kg/m2 and a body weight of 50 kg or higher
- Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator.
- Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator.
Key exclusion criteria (9 listed)
- Any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Any history or suspicion of kidney stones.
- Positive for HIV, Hepatitis B, and/or Hepatitis C.
- Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing.
- Undergone major surgery within 3 months prior to Day 1.
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 |
|---|---|---|
| D-0120oral, single dose | Drug | D-0120 Dose 1, D-0120 Dose 2, D-0120 Dose 3, D-0120 Dose 4, D-0120 Dose 5 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 2 weeks
Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs
7 secondary outcomes
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
Time frame: Day-1 through 3
Pharmacokinetic: maximum plasma drug concentration (Cmax)
Time frame: Day-1 through 3
Pharmacokinetic: Time to reach the Cmax (Tmax)
Time frame: Day-1 through 3
Pharmacokinetic: Apparent terminal half-life (t1/2)
Time frame: Day-1 through 3
Pharmacokinetic: Apparent oral clearance (CL/F)
Time frame: Day-1 through 3
Pharmacokinetic: Apparent volume of distribution (Vz/F)
Time frame: Day-1 through 3
PD profile of D-0120 from plasma and urine
Time frame: Day-1 through 3
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 19 Dec 2018.
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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.
Hugh Coleman, MD principal investigator
Covance
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 D-0120 in people with Gout, run by InventisBio 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 6 inclusion and 9 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 19 Dec 2018. 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?
Incidence of Treatment-Emergent Adverse Events (time frame: 2 weeks). 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 19 Dec 2018.