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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02312973

Enrollment

Registered

2014-12-09

Start date

2015-01-14

Completion date

2016-06-01

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency, Chronic

Keywords

Chronic kidney disease, Pharmacokinetics, Hemodialysis, Peritoneal dialysis, Erythropoietin

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.

Interventions

DRUGMolidustat(BAY85-3934)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics characterized by (AUCnorm) of Molidustat	Up to 96 hours post dose	AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight
Pharmacokinetics characterized by Cmax of Molidustat	Up to 96 hours post dose	Cmax: maximum drug concentration in plasma after single dose administration
Pharmacokinetics characterized by AUC of Molidustat	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	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

Secondary

Measure	Time frame	Description
Pharmacokinetics characterized by Cmax of erythropoietin	Up to 48 hours post dose	Cmax: maximum drug concentration in plasma after single dose administration
Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin	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	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)	Up to 7 days post dose	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026