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

Bayer

Status and phase: Completed; Phase 1

Conditions: Renal Insufficiency, Chronic

Treatments: Drug: Molidustat(BAY85-3934)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02312973

17767

2014-003292-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Arm 1

Experimental group

Description:

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

Treatment:

Drug: Molidustat(BAY85-3934)

Drug: Molidustat(BAY85-3934)

Arm 2

Experimental group

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)

Treatment:

Drug: Molidustat(BAY85-3934)

Drug: Molidustat(BAY85-3934)

Arm 3

Experimental group

Description:

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

Treatment:

Drug: Molidustat(BAY85-3934)

Drug: Molidustat(BAY85-3934)