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

NCT ID: NCT04303039

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-22
• Study Completion Date: 2020-06-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A

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

Group Type: EXPERIMENTAL

ABP-671

Intervention Type: DRUG

ABP-671 Tablet 1.0 mg

Treatment B

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

Group Type: EXPERIMENTAL

ABP-671

Intervention Type: DRUG

ABP-671 Tablet 1.0 mg

Interventions

ABP-671

ABP-671 Tablet 1.0 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• Recent blood donation for more than 500 mL within 2 months of screening.
• 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

Atom Therapeutics Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pharmaron CPC, Inc.

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

ABP-671-103

Identifier Type: -

Identifier Source: org_study_id