Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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AKB-6548

Group Type EXPERIMENTAL

AKB-6548

Intervention Type DRUG

AKB-6548 plus Ferrous Sulfate

AKB-6548 plus ferrous sulfate

Group Type EXPERIMENTAL

AKB-6548

Intervention Type DRUG

Ferrous Sulfate

Intervention Type DRUG

Interventions

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AKB-6548

Intervention Type DRUG

Ferrous Sulfate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes