NCT02327546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

Same day

First QC Date

December 23, 2014

Last Update Submit

November 10, 2018

Conditions

Healthy Volunteers

Keywords

PharmacokineticsAnemiaChronic kidney diseaseCKDChronic renal insufficiencyRenal impairmentFerrous sulfateIronDrug-drug interactionEnd stage renal diseaseDialysisErythropoietinOral anemia treatmentHypoxia-induciable factorHIFHypoxia-induciable factor prolyl-hydroxylase inhibitorHIF-PHI

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (14)

  • 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

  • +9 more secondary outcomes

Study Arms (2)

AKB-6548

EXPERIMENTAL

AKB-6548

Drug: AKB-6548

AKB-6548 plus Ferrous Sulfate

EXPERIMENTAL

AKB-6548 plus ferrous sulfate

Drug: AKB-6548Drug: Ferrous Sulfate

Interventions

AKB-6548DRUG
AKB-6548AKB-6548 plus Ferrous Sulfate
Ferrous SulfateDRUG
AKB-6548 plus Ferrous Sulfate

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

AnemiaRenal Insufficiency, ChronicRenal InsufficiencyKidney Failure, Chronic

Interventions

vadadustatferrous sulfate

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Akebia Therapeutics

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2014

First Posted

December 30, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

US(1)