Trial | NCT03291782  Report issue

Title

D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Gout

  • Intervention/Treatment

    D-0120

  • Study Participants

    39
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 Started
Sep 13
2017
Primary Completion
Apr 06
2018
Study Completion
Aug 06
2018
Last Update
Dec 19
2018

Drug D-0120

oral, single dose

D-0120 Dose 1 Experimental

D-0120 Dose 1 Patients will get D-0120 single agent or placebo of matching size during dose escalation

D-0120 Dose 2 Experimental

D-0120 Dose 2 Patients will get D-0120 single agent or placebo of matching size during dose escalation

D-0120 Dose 3 Experimental

D-0120 Dose 3 Patients will get D-0120 single agent or placebo of matching size during dose escalation

D-0120 Dose 4 Experimental

D-0120 Dose 4 Patients will get D-0120 single agent or placebo of matching size during dose escalation

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.

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.
No Results Posted