Trial Condition(s):
Renal Insufficiency, Chronic
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 Identifier:
17767
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Velbert, Germany, 42549 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
3
Primary Outcome
- Pharmacokinetics characterized by Cmax of MolidustatCmax: maximum drug concentration in plasma after single dose administrationTimeframe: Up to 96 hours post dose
- Pharmacokinetics characterized by AUC of MolidustatAUC: area under the plasma concentration vs time curve from zero to infinityTimeframe: Up to 96 hours post dose
- Pharmacokinetics characterized by Cmax,norm of MolidustatCmax,norm;maximum drug concentration in plasma after single dose administration divided by dose (milligrams) per kilogram body weightTimeframe: Up to 96 hours post dose
- Pharmacokinetics characterized by (AUCnorm) of MolidustatAUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weightTimeframe: Up to 96 hours post dose
Secondary Outcome
- Pharmacokinetics characterized by Cmax of erythropoietinCmax: maximum drug concentration in plasma after single dose administrationTimeframe: Up to 48 hours post dose
- Pharmacokinetics characterized by AUC (0-tlast) of erythropoietinAUC(0-tlast): AUC from time 0 to the last data point above lower limit of quantificationTimeframe: Up to 48 hours post dose
- Pharmacokinetics characterized by tmax of erythropoietintmax: time to reach maximum drug concentration in plasma after single (first) doseTimeframe: Up to 48 hours post dose
- Number of subjects with Treatment Emergent Adverse Event (TEAE)Timeframe: Up to 7 days post dose
Additional Information
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