A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671

A Randomized, Double-Blind, Placebo-Controlled Phase 1b Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 Administered Orally for 10 Days in Subjects With Hyperuricemia

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of ABP-671 administered orally in subjects with hyperuricemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must be medically documented as healthy and acceptable at screening.
  • Subjects must have serum uric acid level at screening ≥ 7.0 mg/dL for men, ≥ 6.0 mg/dL for women.
  • Subjects must have a Body Mass Index (BMI) between 18.0 and 34.0 kg/m2 (inclusive).
  • Subjects must have a body weight of 50 kg or higher.
  • The subject agrees to abstain from alcohol consumption for 48 hours prior to dosing, for the duration of the in-house study period, and for 48 hours prior to each in-clinic follow up visit.
  • The subject is a nonsmoker.
  • Women must be non-pregnant and non-lactating, and either surgically sterile or postmenopausal for ≥ 12 months.
  • Men must be surgically sterile, abstinent or if engaged in sexual relations with a female partner of child-bearing potential, the participant must be using a condom with spermicide from Screening and for a period of 30 days after the last dose of Study Drug. The Investigator will assess the adequacy of methods of contraception on a case-by-case basis.
  • Subjects must have a complete blood count (CBC) and platelet count within the normal range or considered not clinically significant by the principal investigator.
  • Other than elevated serum uric acid, subjects must have normal blood chemistry or results considered not clinically significant by the investigator.
  • Subjects must have a normal urinalysis or results considered not clinically significant by the investigator including a normal protein/creatinine ratio per local lab reference ranges (≤ 200 mg/g) and a urine creatinine result that does not exceed 300 mg/dL. Any out of range values may be repeated per Investigator discretion.
  • Subjects must have a normal ECG or results considered not clinically significant by the principal investigator.
  • Subjects must be able to comply with the study and follow-up procedures.
  • Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.

Exclusion Criteria:

  • Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
  • Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen, and/or Hepatitis C virus.
  • Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 3 weeks before Day 1 of study medication dosing.
  • Subjects who are positive for urine drug and alcohol screening tests.
  • Subjects who have 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, whichever is longer, prior to Day 1 study medication dosing.
  • Recent blood donation for more than 500 mL within 2 months of screening.
  • Abnormal ECG including QTc > 470 (F) and > 450 (M).
  • 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.
  • Prior exposure to ABP-671.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment with ABP-671
Three sequential dose escalation cohorts of ABP-671 administered orally for 10 days.
ABP-671 is an investigational drug
PLACEBO_COMPARATOR: Treatment with placebo
Three sequential dose escalation cohorts of ABP-671 matching placebo administered orally for 10 days.
Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: 38 days
Measured by the number of patients with AEs
38 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration of ABP-671 (Cmax)
Time Frame: 2 weeks
2 weeks
Area under time-concentration curve (AUC)
Time Frame: 2 weeks
2 weeks
Time of maximum observed plasma concentration of ABP-671 (Tmax)
Time Frame: 2 weeks
2 weeks
Volume of distribution (Vd)
Time Frame: 2 weeks
2 weeks
Half life of ABP-671 (t1/2)
Time Frame: 2 weeks
2 weeks
The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid
Time Frame: 24 days
24 days
The effect of ABP-671 versus placebo on change in urine uric acid excretion
Time Frame: 24 days
24 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 5, 2019

Primary Completion (ACTUAL)

December 29, 2019

Study Completion (ACTUAL)

February 7, 2020

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 15, 2019

First Posted (ACTUAL)

August 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABP-671-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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