NCT03906006

Brief Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ABP-671 administered orally in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

April 4, 2019

Last Update Submit

July 27, 2020

Conditions

GoutHyperuricemia

Keywords

gouthyperuricemia

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events

    Incidence of adverse events

    baseline to 7 days

  • Maximum tolerable dose

    Maximum tolerable dose

    baseline to 7 days

Secondary Outcomes (6)

  • Peak plasma concentration

    baseline to 72 hours

  • half-life

    baseline to 72 hours

  • area under the curve

    baseline to 72 hours

  • volume of distribution

    baseline to 72 hours

  • level of serum and urine uric acid

    baseline to 72 hours

  • +1 more secondary outcomes

Study Arms (4)

ABP-671, Cohort 1-

EXPERIMENTAL

ABP-671, Cohort 1 participants received 50 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).

Drug: ABP-671Other: Placebo

ABP-671, Cohort 2-

EXPERIMENTAL

ABP-671, Cohort 2 participants will receive 0.1 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).

Drug: ABP-671Other: Placebo

ABP-671, Cohort 3-

EXPERIMENTAL

ABP-671, Cohort 3 participants will receive 0.5 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).

Drug: ABP-671Other: Placebo

ABP-671, Cohort 4-

EXPERIMENTAL

ABP-671, Cohort 4 participants will receive 1.0 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).

Drug: ABP-671Other: Placebo

Interventions

ABP-671DRUG

Drug: ABP-671, single oral dose

ABP-671, Cohort 1-ABP-671, Cohort 2-ABP-671, Cohort 3-ABP-671, Cohort 4-
PlaceboOTHER

Other: Placebo, single oral dose

ABP-671, Cohort 1-ABP-671, Cohort 2-ABP-671, Cohort 3-ABP-671, Cohort 4-

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, and vital signs.
  • Participants serum uric acid level at screening ≥ 4.0 mg/dL to ≤ 5.5 mg/dL for males, and ≥ 4.0 mg/dL to ≤ 5.0 mg/dL for females.
  • Participants must have a body mass index (BMI) between 18 and 32 kg/m2 and a body weight of 50 kg or higher.
  • Participants must have normal blood chemistry or results considered not clinically significant by the investigator including electrolytes, alkaline phosphatase, total protein, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, uric acid, creatinine, blood urea nitrogen (BUN), and glucose at Screening Visit and at Pre-dose Visit.
  • Participants are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.

You may not qualify if:

  • Participants with any history or clinical manifestations of significant metabolic, hematological, pulmonary, including latent tuberculosis, cardiovascular, gastrointestinal including cholecystectomy, neurologic, hepatic, renal, urological, or psychiatric disorders.
  • Participants who have any history or suspicion of kidney stones.
  • Participants who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing. Females who have received hormone replacement therapy (HRT) within 28 days prior to dosing.
  • Women who are pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

GoutHyperuricemia

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Danielle Armas, M.D.

    Celerion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 8, 2019

Study Start

October 17, 2018

Primary Completion

June 20, 2019

Study Completion

June 20, 2019

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

US(1)