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NCT Number: NCT02312973

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

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.

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Velbert, North Rhine-Westphalia, Germany

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Molidustat(BAY85-3934)

Drug

Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis

Primary outcomes

  1. Pharmacokinetics characterized by Cmax of Molidustat

    Time frame: Up to 96 hours post dose

    Cmax: maximum drug concentration in plasma after single dose administration

  2. 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

  3. 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

  4. 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 outcomes

  1. Pharmacokinetics characterized by Cmax of erythropoietin

    Time frame: Up to 48 hours post dose

    Cmax: maximum drug concentration in plasma after single dose administration

  2. 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

  3. 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

  4. Number of subjects with Treatment Emergent Adverse Event (TEAE)

    Time frame: Up to 7 days post dose

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Dec 9, 2014
Registry last updated
Jan 25, 2021

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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