Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects

Akebia Therapeutics18 enrolled

Overview

The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed and fasted conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AKB-6548 tablet, reference formulation given in the fasted stateDRUG

AKB-6548 tablet, test formulation given in the fasted state.DRUG

AKB-6548 tablet, test formulation given in the fed stateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male and female subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/m2, inclusive. Exclusion Criteria: * Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease. * Positive serology results for HBsAg, HCV, and HIV at Screening. * Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of \<65 mL/min * Known active cancer (except non-melanoma skin cancer) or history of chemotherapy use within the previous 24 months. * Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug. * Subjects with a known history of smoking and/or have used nicotine or nicotine-containing products within the past 6 months.

Locations (1)

Unnamed facility

Kalamazoo, Michigan, United States

Outcomes

Primary Outcomes

Bioavailability endpoints: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) of AKB-6548