Trial Condition(s):
Clinical Pharmacology
Finerenone/digoxin drug-drug interaction study
Bayer Identifier:
14505
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The primary objective of the study was to investigate the influence of a concomitant intake of multiple doses of 20 mg finerenone administered once-daily (od) for 10 days on the steady-state pharmacokinetics of digoxin (0.375 mg od).
The secondary objective was to assess the safety and tolerability of the combined administration of both drugs and to determine the influence of multiple doses of digoxin (0.375 mg od) on the pharmacokinetics of a single dose of 20 mg finerenone.
Inclusion Criteria
- Healthy male subjects, white, age: 18 to 45 years, body mass index: ≥ 18.0 and ≤ 29.9 kg/m².
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 | Status | |
|---|---|---|
Locations Investigative Site Mannheim, Germany, 68167 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Randomized, non-blind, non-placebo-controlled, 2-fold cross-over study with additional 1st period with fixed treatment to investigate the pharmacokinetic interaction between finerenone (20 mg once-daily) and digoxin (0.375 mg once-daily) and to investigate the safety and tolerability of the combined administration in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
N/A
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Area Under the Concentration Versus Time Curve During Any Dose Interval at Steady State (AUCtau,ss) of Digoxin on Day 10Timeframe: 0 hour (h) (pre-dose) to 24 h post-dose following the dose on day 10 of treatment period 2 and 3
- Drug Concentration in Plasma at Steady State (Ctrough,ss) at Pre-dose of Digoxin on Day 8, 9, and 10Timeframe: Pre-dose on treatment Day 8, 9, and 10
Secondary Outcome
- Number of Subjects With Treatment Emergent Adverse Events (TEAEs)-OverallTimeframe: From start of study treatment until 7 days after last administration of the study medication
Additional Information
Not Available
Copyright © Bayer
Powered by
