To Investigate Pharmacokinetics (Absorption, Distribution, Elimination), Safety and Tolerability of a Single Oral Dose of 75 mg Molidustat Tablet in Male and Female Subjects Requiring Hemo- or Peritoneal Dialysis Compared to Healthy Subjects

Overview

The study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as the safety and tolerability of molidustat.

Full Title of Study: “Investigation of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Oral Doses of 75 mg Molidustat in Male and Female Subjects With Renal Impairment Requiring Hemo- or Peritoneal Dialysis Compared to Age- and Weight-matched Healthy Subjects in a Single-center, Non-controlled, Non-blinded Study With Group Stratification”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2, 2015

Interventions

  • Drug: Molidustat(BAY85-3934)
    • Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis
  • Drug: Molidustat(BAY85-3934)
    • One single oral dose of 75 mg molidustat in healthy subjects

Arms, Groups and Cohorts

  • Experimental: Arm 1
    • Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively)
  • Experimental: Arm 2
    • Single oral dose of 75 mg molidustat (fasted) in subjects on peritoneal dialysis (after start of peritoneal dialysis intervall and, optionally, after the start of a peritoneal dialysis-free intervall,respectively)
  • Experimental: Arm 3
    • Single oral dose of 75 mg molidustat (fasted) in healthy subjects

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics characterized by Cmax of Molidustat
    • Time Frame: Up to 96 hours post dose
    • Cmax: maximum drug concentration in plasma after single dose administration
  • Pharmacokinetics characterized by AUC of Molidustat
    • Time Frame: Up to 96 hours post dose
    • AUC: area under the plasma concentration vs time curve from zero to infinity
  • Pharmacokinetics characterized by Cmax,norm of Molidustat
    • Time Frame: Up to 96 hours post dose
    • Cmax,norm;maximum drug concentration in plasma after single dose administration divided by dose (milligrams) per kilogram body weight
  • Pharmacokinetics characterized by (AUCnorm) of Molidustat
    • Time Frame: Up to 96 hours post dose
    • AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight

Secondary Measures

  • Pharmacokinetics characterized by Cmax of erythropoietin
    • Time Frame: Up to 48 hours post dose
    • Cmax: maximum drug concentration in plasma after single dose administration
  • Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin
    • Time Frame: Up to 48 hours post dose
    • AUC(0-tlast): AUC from time 0 to the last data point above lower limit of quantification
  • Pharmacokinetics characterized by tmax of erythropoietin
    • Time Frame: Up to 48 hours post dose
    • tmax: time to reach maximum drug concentration in plasma after single (first) dose
  • Number of subjects with Treatment Emergent Adverse Event (TEAE)
    • Time Frame: Up to 7 days post dose

Participating in This Clinical Trial

Inclusion Criteria

  • Male and female (without childbearing potential) – Age: ≥18 and ≤79 years of age – Body mass index (BMI): ≥18 and ≤34 kg/m2 – Ethnicity: White – Subjects with severe renal impairment on hemodialysis or peritoneal dialysis, and – Healthy subjects Exclusion Criteria:

  • Women of childbearing potential, pregnant or lactating women – Use of medication within the 2 weeks preceding the study which could interfere with the investigational product – Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab), human immune deficiency virus 1 and 2 antibodies (HIV 1/2 Ab) – Exclusion periods from other studies or simultaneous participation in other clinical studies

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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