Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency, Chronic
Keywords: Chronic kidney disease
Pharmacokinetics
Hemodialysis
Peritoneal dialysis
Erythropoietin
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Pharmacokinetics characterized by Cmax of Molidustat
timeFrame: Up to 96 hours post dose
measure: Pharmacokinetics characterized by AUC of Molidustat
timeFrame: Up to 96 hours post dose
measure: Pharmacokinetics characterized by Cmax,norm of Molidustat
timeFrame: Up to 96 hours post dose
measure: Pharmacokinetics characterized by (AUCnorm) of Molidustat
timeFrame: Up to 96 hours post dose
Secondary outcomes:
measure: Pharmacokinetics characterized by Cmax of erythropoietin
timeFrame: Up to 48 hours post dose
measure: Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin
timeFrame: Up to 48 hours post dose
measure: Pharmacokinetics characterized by tmax of erythropoietin
timeFrame: Up to 48 hours post dose
measure: Number of subjects with Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to 7 days post dose
Other outcomes:
Locations:
city: Velbert
country: Germany
state: Nordrhein-Westfalen
city: Kiel
country: Germany
state: Schleswig-Holstein
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: