check_circleStudy Completed

Renal Insufficiency, Chronic

Bayer Identifier:

17767

ClinicalTrials.gov Identifier:

NCT02312973

EudraCT Number:

2014-003292-31

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 79 years
  • - 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

  • - 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

Trial summary

Enrollment Goal
40
Trial Dates
January 2015 - June 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Molidustat (BAY85-3934)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Kiel, 24105, Germany
Completed
Velbert, 42549, Germany

Primary Outcome

  • Pharmacokinetics characterized by Cmax of Molidustat
    Cmax: maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Up to 96 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics characterized by AUC of Molidustat
    AUC: area under the plasma concentration vs time curve from zero to infinity
    date_rangeTime Frame:
    Up to 96 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics characterized by Cmax,norm of Molidustat
    Cmax,norm;maximum drug concentration in plasma after single dose administration divided by dose (milligrams) per kilogram body weight
    date_rangeTime Frame:
    Up to 96 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics characterized by (AUCnorm) of Molidustat
    AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight
    date_rangeTime Frame:
    Up to 96 hours post dose
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Pharmacokinetics characterized by Cmax of erythropoietin
    Cmax: maximum drug concentration in plasma after single dose administration
    date_rangeTime Frame:
    Up to 48 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin
    AUC(0-tlast): AUC from time 0 to the last data point above lower limit of quantification
    date_rangeTime Frame:
    Up to 48 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics characterized by tmax of erythropoietin
    tmax: time to reach maximum drug concentration in plasma after single (first) dose
    date_rangeTime Frame:
    Up to 48 hours post dose
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects with Treatment Emergent Adverse Event (TEAE)
    date_rangeTime Frame:
    Up to 7 days post dose
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

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