Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548

Akebia Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AKB-6548; Drug: Ferrous Sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02327546

AKB-6548-CI-0012

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

AKB-6548

Experimental group

Description:

AKB-6548

Treatment:

Drug: AKB-6548

AKB-6548 plus Ferrous Sulfate

Experimental group

Description:

AKB-6548 plus ferrous sulfate

Treatment:

Drug: Ferrous Sulfate

Drug: AKB-6548