A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
- Registration Number
- NCT04060173
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Treatment with placebo Placebo Three sequential dose escalation cohorts of ABP-671 matching placebo administered orally for 10 days. Treatment with ABP-671 ABP-671 Three sequential dose escalation cohorts of ABP-671 administered orally for 10 days.
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) 38 days Measured by the number of patients with AEs
- Secondary Outcome Measures
Name Time Method Area under time-concentration curve (AUC) 2 weeks Maximum observed plasma concentration of ABP-671 (Cmax) 2 weeks Volume of distribution (Vd) 2 weeks Half life of ABP-671 (t1/2) 2 weeks The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid 24 days The effect of ABP-671 versus placebo on change in urine uric acid excretion 24 days Time of maximum observed plasma concentration of ABP-671 (Tmax) 2 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular targets of ABP-671 in managing hyperuricemia and gout?
How does ABP-671 compare to standard urate-lowering therapies in safety and efficacy profiles?
Which biomarkers correlate with ABP-671's pharmacodynamic effects in hyperuricemic patients?
What adverse event patterns emerged in NCT04060173's Phase 1b oral ABP-671 trial for gout?
Are there combination therapies involving ABP-671 for treating refractory gout or comorbid conditions?
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States
Celerion🇺🇸Tempe, Arizona, United States