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Completed

NCT Number: NCT02327546

Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548

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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Key information

Conditions

Healthy Volunteers Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kalamazoo, Michigan, 49007, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AKB-6548

Drug

Ferrous Sulfate

Drug

Primary outcomes

  1. PK parameters of AKB-6548: Maximum plasma concentration (Cmax)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  2. PK parameters of AKB-6548: Area under the curve from time 0 until the last quantifiable concentration (AUC [last])

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  3. PK parameters of AKB-6548: Area under the concentration-time curve from 0 to infinity (AUCinf)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

Secondary outcomes

  1. PK parameters of AKB-6548: Time to maximum plasma concentration (Tmax)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  2. PK parameters of AKB-6548: Terminal elimination rate constant (λz)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  3. PK parameters of AKB-6548: Plasma half life (t1/2)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  4. PK parameters of AKB-6548: Apparent total systemic clearance (CL/F)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  5. PK parameters of AKB-6548: Apparent volume of distribution during the terminal elimination phase (VzF)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  6. PK parameters of AKB-6548 metabolites: Maximum plasma concentration (Cmax)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  7. PK parameters of AKB-6548 metabolites: Time to maximum plasma concentration (Tmax)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  8. PK parameters of AKB-6548 metabolites: Terminal elimination rate constant (λz)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  9. PK parameters of AKB-6548 metabolites: Plasma half life (t1/2)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  10. PK parameters of AKB-6548 metabolites: Area under the curve from time 0 until the last quantifiable concentration (AUC [last])

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  11. PK parameters of AKB-6548 metabolites: Area under the concentration-time curve from 0 to infinity (AUCinf)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  12. Ratio of metabolite to parent drug for maximum plasma concentration (Cmax)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  13. Ratio of metabolite to parent drug for are under the curve from time 0 until the last quantifiable concentration (AUC [last])

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

  14. Ratio of metabolite to parent drug for area under the concentration-time curve (AUC)

    Time frame: Multiple timepoint evaluations from pre-dose to 24 hours post-dose

Sponsors and collaborators

Lead sponsor

Akebia Therapeutics

Industry

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 30, 2014
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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