Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects

NCT04303039 | Completed Phase 1 FDA Drug

• 1 other identifier: ABP-671-103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, open-label, single-dose, 2-way randomized crossover design in which 12 healthy subjects will be randomized to 1 of 2 treatment sequences (AB or BA). Treatments A and B will consist of single oral dose of tablet formulation (1.0 mg as 1 x 1.0 mg) in the fasted and fed state administered with approximately 240 mL of water. Each period will be separated by a washout interval of 4 days.

Conditions

Gout; Food-drug Interaction

Outcome Measures

Primary Outcomes (1)

• Plasma ABP-671 Concentration

  At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs.

  72 hours

Secondary Outcomes (4)

• Serum Uric Acid Concentration

  72 hours

• Serum Creatinine Concentration

  72 hours

• Urine Uric Acid Concentration

  72 hours

• Urine Creatinine Concentration

  72 hours

Study Arms (2)

Treatment A

EXPERIMENTAL

Single 1.0 mg dose of ABP-671 in the fasted state.

Drug: ABP-671

Treatment B

EXPERIMENTAL

Single 1.0 mg dose of ABP-671 in the fed state, after a standardized breakfast.

Drug: ABP-671

Interventions

ABP-671 DRUG

ABP-671 Tablet 1.0 mg

Treatment A; Treatment B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged 18 to 60 years, inclusive
• Healthy
• Subjects must have the serum uric acid level at screening ≥ 3.7 mg/dL to ≤ 7.0 mg/dL for males, and ≥ 2.3 mg/dL to ≤ 6.0 mg/dL for females.
• Subjects must have a Body Mass Index (BMI) between 18 and 35 kg/m2 at screening (inclusive).
• Subjects must have a body weight of 50 kg or higher.
• Females must be non-pregnant and non-lactating
• Males must be surgically sterile, abstinent, or if engaged in sexual relations with a female partner of child-bearing potential, be using a condom with spermicide
• Subjects must have a CBC and platelet count within normal range
• Subjects must have normal blood chemistry
• Subjects must have a normal urinalysis

You may not qualify if:

• Subjects must have a normal estimated glomerular filtration rate
• Subjects must have a normal ECG
• 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 provided signed informed consent to participate in the study
• Subjects 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.
• Subjects with prior history of bariatric surgery, intestinal resection, malabsorption, or celiac disease with an exception of subjects with appendectomy.
• Subjects who have any history or suspicion of kidney stones or evidence of renal stones or opacification with renal ultrasound prior to dosing on Day -1.
• Subjects who have any history of gout.
• 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 14 days screening period before Day 1 of study medication dosing. Females who have received hormone replacement therapy (HRT) within 14 days prior to dosing.
• Subjects who are positive for urine drug 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.
• Subjects who previously received ABP-671.

Sponsors & Collaborators

• Atom Therapeutics Co., Ltd: lead

Study Sites (1)

Pharmaron CPC, Inc.

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: May 22, 2020
• Primary Completion: June 9, 2020
• Study Completion: June 19, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)