Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AKB-6548; Drug: Ferrous Sulfate

• Registration Number: NCT02327546
• Lead Sponsor: Akebia Therapeutics

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2014-12
• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-30
• Study Completion: 2015-02
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-10
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AKB-6548 plus Ferrous Sulfate	AKB-6548	AKB-6548 plus ferrous sulfate
AKB-6548	AKB-6548	AKB-6548
AKB-6548 plus Ferrous Sulfate	Ferrous Sulfate	AKB-6548 plus ferrous sulfate

Primary Outcome Measures

Name	Time	Method
PK parameters of AKB-6548: Maximum plasma concentration (Cmax)	Multiple timepoint evaluations from pre-dose to 24 hours post-dose
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
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 Outcome Measures

Name	Time	Method
PK parameters of AKB-6548: Time to maximum plasma concentration (Tmax)	Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Terminal elimination rate constant (λz)	Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Plasma half life (t1/2)	Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548: Apparent total systemic clearance (CL/F)	Multiple timepoint evaluations from pre-dose to 24 hours post-dose
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
PK parameters of AKB-6548 metabolites: Maximum plasma concentration (Cmax)	Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Time to maximum plasma concentration (Tmax)	Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Terminal elimination rate constant (λz)	Multiple timepoint evaluations from pre-dose to 24 hours post-dose
PK parameters of AKB-6548 metabolites: Plasma half life (t1/2)	Multiple timepoint evaluations from pre-dose to 24 hours post-dose
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
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
Ratio of metabolite to parent drug for maximum plasma concentration (Cmax)	Multiple timepoint evaluations from pre-dose to 24 hours post-dose
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
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