Clinical trial NCT03291782: D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 2 weeks
Secondary outcomes:
measure: Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
timeFrame: Day-1 through 3
measure: Pharmacokinetic: maximum plasma drug concentration (Cmax)
timeFrame: Day-1 through 3
measure: Pharmacokinetic: Time to reach the Cmax (Tmax)
timeFrame: Day-1 through 3
measure: Pharmacokinetic: Apparent terminal half-life (t1/2)
timeFrame: Day-1 through 3
measure: Pharmacokinetic: Apparent oral clearance (CL/F)
timeFrame: Day-1 through 3
measure: Pharmacokinetic: Apparent volume of distribution (Vz/F)
timeFrame: Day-1 through 3
measure: PD profile of D-0120 from plasma and urine
timeFrame: Day-1 through 3
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Daytona Beach Clinical Research Unit
state: Florida
Study officials:
affiliation: Covance
name: Hugh Coleman, MD
role: PRINCIPAL_INVESTIGATOR
References: