Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03291782
Other study ID # IBIO-201
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04060173 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 Phase 1
Not yet recruiting NCT06187519 - UR+AIMS Gout Wearable Skin Uric Acid Monitor Study N/A
Completed NCT03635957 - Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout Phase 4
Completed NCT04966325 - Thorough QT (TQT) Study to Evaluate the Effect of LC350189 on Cardiac Repolarization in Healthy Male and Female Subjects Early Phase 1
Completed NCT03015948 - A Single Dose Study of SHR4640 in Healthy Male Volunteers Phase 1
Completed NCT02855437 - Novel Methods for Ascertainment of Gout Flares -A Pilot Study N/A
Active, not recruiting NCT02702375 - Meta-analyses of Impotrant Food Sources of Sugars and Incident Cardiometabolic Diseases N/A
Completed NCT01407874 - A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency Phase 2
Completed NCT00985127 - Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout Phase 2
Completed NCT00995618 - Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia Phase 2
Terminated NCT04987294 - Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease Phase 2
Recruiting NCT03388515 - A Study to Assess the Safety and Tolerability of SSS11 in Healthy Subjects. Phase 1
Completed NCT06189404 - Effect of Tigulixostat on the Pharmacokinetics of Theophylline Phase 1
Enrolling by invitation NCT03336203 - The Impact of Urate-lowering Therapy on Kidney Function (IMPULsKF) Phase 4
Recruiting NCT05586958 - Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients Phase 3
Recruiting NCT04047394 - A Study to Determine the Safety, Tolerability, PK and Preliminary PD of SSS11 in Chinese Healthy Adult Volunteers Phase 1
Not yet recruiting NCT05507723 - Tight Control of Gouty Arthritis Compared to Usual Care N/A
Recruiting NCT06056570 - Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia Phase 1/Phase 2
Completed NCT02557126 - Study of URC102 to Assess the Safety and Efficacy in Gout Patients Phase 2
Completed NCT02246673 - RDEA3170 and Febuxostat Combination Study in Gout Subjects Phase 2