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

Gout Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291782
• Other study ID #: IBIO-201
• Status: Completed
• Phase: Phase 1
• Start date: September 13, 2017
• Est. completion date: August 6, 2018

Study information

• Verified date: June 2018
• Source: InventisBio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 6, 2018
• Est. primary completion date: April 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• D-0120
oral, single dose

Locations

Country	Name	City	State
United States	Covance Daytona Beach Clinical Research Unit	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
InventisBio Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs	2 weeks
Secondary	Pharmacokinetic: area under the plasma concentration versus time curve (AUC)	AUC: area under the plasma concentration versus time curve for D-0120	Day-1 through 3
Secondary	Pharmacokinetic: maximum plasma drug concentration (Cmax)	Cmax: maximum plasma drug concentration of D-0120	Day-1 through 3
Secondary	Pharmacokinetic: Time to reach the Cmax (Tmax)	Tmax: Time to reach the Cmax of D-0120	Day-1 through 3
Secondary	Pharmacokinetic: Apparent terminal half-life (t1/2)	t1/2: apparent terminal half-life of D-0120	Day-1 through 3
Secondary	Pharmacokinetic: Apparent oral clearance (CL/F)	CL/F: Apparent oral clearance of D-0120	Day-1 through 3
Secondary	Pharmacokinetic: Apparent volume of distribution (Vz/F)	Vz/F: Apparent volume of distribution of D-0120	Day-1 through 3
Secondary	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 %)	Day-1 through 3