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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

Primary Purpose

Renal Insufficiency, Chronic

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Molidustat(BAY85-3934)
Molidustat(BAY85-3934)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Insufficiency, Chronic focused on measuring Chronic kidney disease, Pharmacokinetics, Hemodialysis, Peritoneal dialysis, Erythropoietin

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively)

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)

Single oral dose of 75 mg molidustat (fasted) in healthy subjects

Outcomes

Primary Outcome Measures

Pharmacokinetics characterized by Cmax of Molidustat
Cmax: maximum drug concentration in plasma after single dose administration
Pharmacokinetics characterized by AUC of Molidustat
AUC: area under the plasma concentration vs time curve from zero to infinity
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
Pharmacokinetics characterized by (AUCnorm) of Molidustat
AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight

Secondary Outcome Measures

Pharmacokinetics characterized by Cmax of erythropoietin
Cmax: maximum drug concentration in plasma after single dose administration
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
Pharmacokinetics characterized by tmax of erythropoietin
tmax: time to reach maximum drug concentration in plasma after single (first) dose
Number of subjects with Treatment Emergent Adverse Event (TEAE)

Full Information

First Posted
December 5, 2014
Last Updated
January 22, 2021
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02312973
Brief Title
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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2015 (Actual)
Primary Completion Date
December 2, 2015 (Actual)
Study Completion Date
June 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
Chronic kidney disease, Pharmacokinetics, Hemodialysis, Peritoneal dialysis, Erythropoietin

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively)
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
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)
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Single oral dose of 75 mg molidustat (fasted) in healthy subjects
Intervention Type
Drug
Intervention Name(s)
Molidustat(BAY85-3934)
Intervention Description
Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis
Intervention Type
Drug
Intervention Name(s)
Molidustat(BAY85-3934)
Intervention Description
One single oral dose of 75 mg molidustat in healthy subjects
Primary Outcome Measure Information:
Title
Pharmacokinetics characterized by Cmax of Molidustat
Description
Cmax: maximum drug concentration in plasma after single dose administration
Time Frame
Up to 96 hours post dose
Title
Pharmacokinetics characterized by AUC of Molidustat
Description
AUC: area under the plasma concentration vs time curve from zero to infinity
Time Frame
Up to 96 hours post dose
Title
Pharmacokinetics characterized by Cmax,norm of Molidustat
Description
Cmax,norm;maximum drug concentration in plasma after single dose administration divided by dose (milligrams) per kilogram body weight
Time Frame
Up to 96 hours post dose
Title
Pharmacokinetics characterized by (AUCnorm) of Molidustat
Description
AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight
Time Frame
Up to 96 hours post dose
Secondary Outcome Measure Information:
Title
Pharmacokinetics characterized by Cmax of erythropoietin
Description
Cmax: maximum drug concentration in plasma after single dose administration
Time Frame
Up to 48 hours post dose
Title
Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin
Description
AUC(0-tlast): AUC from time 0 to the last data point above lower limit of quantification
Time Frame
Up to 48 hours post dose
Title
Pharmacokinetics characterized by tmax of erythropoietin
Description
tmax: time to reach maximum drug concentration in plasma after single (first) dose
Time Frame
Up to 48 hours post dose
Title
Number of subjects with Treatment Emergent Adverse Event (TEAE)
Time Frame
Up to 7 days post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Velbert
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42549
Country
Germany
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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