D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Gout |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 12/20/2018 |
| Start Date: | September 13, 2017 |
| End Date: | August 6, 2018 |
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.
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.
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.
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