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

NCT ID: NCT03291782

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-13

Study Completion Date

2018-08-06

Brief Summary

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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.

Detailed Description

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Conditions

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Gout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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D-0120 Dose 1

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

Group Type EXPERIMENTAL

D-0120

Intervention Type DRUG

oral, single dose

D-0120 Dose 2

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

Group Type EXPERIMENTAL

D-0120

Intervention Type DRUG

oral, single dose

D-0120 Dose 3

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

Group Type EXPERIMENTAL

D-0120

Intervention Type DRUG

oral, single dose

D-0120 Dose 4

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

Group Type EXPERIMENTAL

D-0120

Intervention Type DRUG

oral, single dose

D-0120 Dose 5

D-0120 Dose 5 Patients will get D-0120 single agent once in the fasted state and once in the fed state.

Group Type EXPERIMENTAL

D-0120

Intervention Type DRUG

oral, single dose

Interventions

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D-0120

oral, single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InventisBio Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugh Coleman, MD

Role: PRINCIPAL_INVESTIGATOR

Covance

Locations

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Covance Daytona Beach Clinical Research Unit

Daytona Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IBIO-201

Identifier Type: -

Identifier Source: org_study_id