Trial Condition(s):
Clinical Pharmacology
Single / multiple dose study in Chinese subjects
Bayer Identifier:
16537
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Primary objective was
• to investigate the pharmacokinetics (PK) of finerenone in Chinese healthy male subjects
Secondary objective was
• to investigate the safety and tolerability of finerenone in Chinese healthy male subjects
Inclusion Criteria
- Healthy male Chinese subjects, aged ≥ 18 to ≤ 45 years, with a body mass index (BMI) ≥ 19.0 and ≤ 24 kg/m^2.
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations The 307th Hospital of Chinese People’s Liberation Army Beijing, China, 100071 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
A single-center, randomized, placebo-controlled, single-blind study to investigate the pharmacokinetics, safety and tolerability of single and multiple oral doses of finerenone in Chinese healthy adult male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Cmax: maximum observed drug concentration in plasma after single dosingTimeframe: Day 1
- AUC: area under the plasma concentration vs. time curve from zero to infinity after single (first) doseTimeframe: Day 1
- Cmax/D: Cmax divided by doseTimeframe: Day 1
- AUC/D: AUC divided by doseTimeframe: Day 1
- Cmax,norm: Cmax divided by dose per body weightTimeframe: Day 1
- AUCnorm: AUC divided by dose per body weightTimeframe: Day 1
- Cmax,md: Cmax after multiple dosingTimeframe: Day 9
- AUCτ,md: AUCτ after multiple dose administrationTimeframe: Day 9
- Cmax,md/D: Cmax,md divided by doseTimeframe: Day 9
- AUCτ,md/D: AUCτ,md divided by doseTimeframe: Day 9
- Cmax,md,norm: Cmax,md divided by dose per body weightTimeframe: Day 9
- AUCτ,md,norm: AUCτ,md divided by dose per body weightTimeframe: Day 9
Secondary Outcome
- Number of participants with Treatment-emergent adverse eventsTimeframe: AE had started or worsened after first administration of study medication up to 3 days after end of treatment
Additional Information
Not Available
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