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

Phase 1

Completed

• Conditions: Renal Insufficiency, Chronic
• Interventions: Drug: Molidustat(BAY85-3934)

• Registration Number: NCT02312973
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-09
• Study Start: 2015-01-14
• Primary Completion: 2015-12-02
• Study Completion: 2016-06-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Molidustat(BAY85-3934)	Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively)
Arm 2	Molidustat(BAY85-3934)	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 3	Molidustat(BAY85-3934)	Single oral dose of 75 mg molidustat (fasted) in healthy subjects

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
Pharmacokinetics characterized by Cmax of erythropoietin	Up to 48 hours post dose	Cmax: maximum drug concentration in plasma after single dose administration
Number of subjects with Treatment Emergent Adverse Event (TEAE)	Up to 7 days post dose