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

Akebia Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AKB-6548 tablet, test formulation given in the fed state; Drug: AKB-6548 tablet, test formulation given in the fasted state.; Drug: AKB-6548 tablet, reference formulation given in the fasted state

Study type: Interventional

Funder types: Industry

Identifiers

NCT02412449

AKB-6548-CI-0013

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Treatment A

Experimental group

Description:

AKB-6548

Treatment:

Drug: AKB-6548 tablet, reference formulation given in the fasted state

Treatment B

Experimental group

Description:

AKB-6548

Treatment:

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

Treatment C

Experimental group

Description:

AKB-6548

Treatment:

Drug: AKB-6548 tablet, test formulation given in the fed state