Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548

Healthy Volunteers Clinical Trial

Official title:

An Open-Label, Randomized, Single-Dose Study to Evaluate the Effects of 325 mg Ferrous Sulfate Tablet (65 mg Iron) on the Pharmacokinetics of 450 mg Dose of AKB-6548 in Healthy Male Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327546
• Other study ID #: AKB-6548-CI-0012
• Status: Completed
• Phase: Phase 1
• Start date: December 2014
• Est. completion date: February 2015

Study information

• Verified date: November 2018
• Source: Akebia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AKB-6548

• Ferrous Sulfate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akebia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters of AKB-6548: Maximum plasma concentration (Cmax)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Primary	PK parameters of AKB-6548: Area under the curve from time 0 until the last quantifiable concentration (AUC [last])		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Primary	PK parameters of AKB-6548: Area under the concentration-time curve from 0 to infinity (AUCinf)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	PK parameters of AKB-6548: Time to maximum plasma concentration (Tmax)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	PK parameters of AKB-6548: Terminal elimination rate constant (?z)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	PK parameters of AKB-6548: Plasma half life (t1/2)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	PK parameters of AKB-6548: Apparent total systemic clearance (CL/F)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	PK parameters of AKB-6548: Apparent volume of distribution during the terminal elimination phase (VzF)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	PK parameters of AKB-6548 metabolites: Maximum plasma concentration (Cmax)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	PK parameters of AKB-6548 metabolites: Time to maximum plasma concentration (Tmax)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	PK parameters of AKB-6548 metabolites: Terminal elimination rate constant (?z)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	PK parameters of AKB-6548 metabolites: Plasma half life (t1/2)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	PK parameters of AKB-6548 metabolites: Area under the curve from time 0 until the last quantifiable concentration (AUC [last])		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	PK parameters of AKB-6548 metabolites: Area under the concentration-time curve from 0 to infinity (AUCinf)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	Ratio of metabolite to parent drug for maximum plasma concentration (Cmax)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	Ratio of metabolite to parent drug for are under the curve from time 0 until the last quantifiable concentration (AUC [last])		Multiple timepoint evaluations from pre-dose to 24 hours post-dose
Secondary	Ratio of metabolite to parent drug for area under the concentration-time curve (AUC)		Multiple timepoint evaluations from pre-dose to 24 hours post-dose