Food-drug Interaction, Gout
Conditions
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.
Interventions
DRUGABP-671
ABP-671 Tablet 1.0 mg
Sponsors
Atom Therapeutics Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 * Subjects meeting inclusion and
Exclusion criteria
must have a renal ultrasound determined to be normal or non-clinically significant * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma ABP-671 Concentration | 72 hours | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Uric Acid Concentration | 72 hours | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. |
| Serum Creatinine Concentration | 72 hours | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. |
| Urine Uric Acid Concentration | 72 hours | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. |
| Urine Creatinine Concentration | 72 hours | At times 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. |
Countries
United States
Outcome results
None listed