NCT02312973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 14, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

December 5, 2014

Last Update Submit

January 22, 2021

Conditions

Renal Insufficiency, Chronic

Keywords

Chronic kidney diseasePharmacokineticsHemodialysisPeritoneal dialysisErythropoietin

Outcome Measures

Primary Outcomes (4)

  • Pharmacokinetics characterized by Cmax of Molidustat

    Cmax: maximum drug concentration in plasma after single dose administration

    Up to 96 hours post dose

  • Pharmacokinetics characterized by AUC of Molidustat

    AUC: area under the plasma concentration vs time curve from zero to infinity

    Up to 96 hours post dose

  • 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

    Up to 96 hours post dose

  • Pharmacokinetics characterized by (AUCnorm) of Molidustat

    AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight

    Up to 96 hours post dose

Secondary Outcomes (4)

  • Pharmacokinetics characterized by Cmax of erythropoietin

    Up to 48 hours post dose

  • Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin

    Up to 48 hours post dose

  • Pharmacokinetics characterized by tmax of erythropoietin

    Up to 48 hours post dose

  • Number of subjects with Treatment Emergent Adverse Event (TEAE)

    Up to 7 days post dose

Study Arms (3)

Arm 1

EXPERIMENTAL

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

Drug: Molidustat(BAY85-3934)

Arm 2

EXPERIMENTAL

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)

Drug: Molidustat(BAY85-3934)

Arm 3

EXPERIMENTAL

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

Drug: Molidustat(BAY85-3934)

Interventions

Molidustat(BAY85-3934)DRUG

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

Arm 1Arm 2

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Velbert, North Rhine-Westphalia, 42549, Germany

Location

Unknown Facility

Kiel, Schleswig-Holstein, 24105, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 9, 2014

Study Start

January 14, 2015

Primary Completion

December 2, 2015

Study Completion

June 1, 2016

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations

DE(2)