Study Completed

Clinical pharmacology

Bayer Identifier:

15841

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-004733-75

EU CT Number:

Not Available

Interaction study of vericiguat with digoxin in healthy male subjects

Trial purpose

The primary objective of this study was to investigate the influence of a concomitant intake of multiple doses of 10 mg vericiguat administered once-daily (od) for 9 days on the steady state PK of digoxin (0.375 mg od).

The secondary objective of this study 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 PK of a single dose of 10 mg vericiguat.

Key Participants Requirements

Sex

Male

Age

18 - 55 Years

Inclusion Criteria
- Healthy male subject
- Age: 18 to 55 years (inclusive) at the first screening examination / visit
- Race: White
- Body mass index: above/equal 18 and below/equal 30 kg/m²
Exclusion Criteria
- Incompletely cured pre-existing diseases for which it was possible to assume that the absorption, distribution, metabolism, elimination and effects of the study drugs would not be normal
- Known hypersensitivity to the study drug (active substances or excipients of the preparations) or digoxin
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Known gastrointestinal (GI) disorders (eg stomach ulcers, duodenal ulcers, GI bleeding) or inflammatory bowel disease (eg Crohn’s disease, ulcerative colitis)
- Subjects with thyroid disorders
- Subjects with Gilbert’s syndrome (associated with the UGT1A1 promoter genotype)
- Hepatic impairment, past or present on day of screening
- Renal impairment, past or present at day of screening
- Diagnosed malignancy, past or present at day of screening

Trial summary

Enrollment Goal

Trial Dates

April 2015 - April 2016

Phase

Phase 1

Could I Receive a placebo

Products

Verquvo (Vericiguat, BAY1021189)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Mannheim, 68167, Germany

Primary Outcome

Area Under the Concentration Versus Time Curve During Dose Interval After Multiple Dose (AUCtau,md) From 0 Hour (Pre-dose) to 24 Hours Post-dose on Day 10 of Digoxin in Plasma
Time Frame:
0 hour (pre-dose) to 24 hours post-dose on Day 10 of Period 2 and 3
Through Concentration of Digoxin in Plasma (Ctrough) on Day 8, Day 9 and Day 10 of Digoxin Administration
Time Frame:
0 hour (pre-dose) to 24 hours post-dose on Day 8, 9, 10 of Period 2 and 3

Secondary Outcome

Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Vericiguat in Plasma
Time Frame:
0 hour (pre-dose) to 48 hours post-dose on Day 1 of Period 1 and Period 3
Maximum Observed Drug Concentration (Cmax) of Vericiguat in Plasma
Time Frame:
0 hour (pre-dose) to 48 hours post-dose on Day 1 of Period 1 and Period 3
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time Frame:
From start of study drug administration until 30 days post study treatment

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 vericiguat (10 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

Basic Science

Allocation

Randomized

Blinding

N/A

Assignment

N/A

Trial Arms