Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548

Akebia Therapeutics10 enrolled

Overview

The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548 with ferrous sulfate relative to AKB-6548 in healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

AKB-6548DRUG

Ferrous SulfateDRUG

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects 18 to 55 years of age with a body mass index between 18 and 30 kg/m2 * Participants and their partners must use a highly effective form of contraception during the study and for 1 month following discharge from the Clinical Research Unit (CRU) * Subjects must discontinue all iron preparations for 14 days prior to study drug administration Exclusion Criteria: * Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease * Positive serology results for HBsAg, HCV, and HIV at Screening * Renal impairment (estimated glomerular filtration rate (eGFR) of \<65mL/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