Drug Interaction Study of Warfarin and MT-3995
A Phase I, Open-label, Single-Centre, Drug-Drug Interaction Study to Evaluate the Influence of MT-3995 on Pharmacokinetics(PK) and Pharmacodynamics of Warfarin in Healthy Subjects
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 4, 2015
CompletedFirst Posted
Study publicly available on registry
August 24, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 9, 2015
October 1, 2015
2 months
August 4, 2015
October 7, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax of warfarin with MT-3995 versus warfarin alone
8 days
AUC of warfarin with MT-3995 versus warfarin alone
8 days
Secondary Outcomes (2)
International normalized ratio (INR) max of warfarin with MT-3995 versus warfarin alone
8 days
INR AUC of warfarin with MT-3995 versus warfarin alone
8 days
Study Arms (1)
Warfarin and MT-3995
EXPERIMENTALSubjects will be administered a single dose of warfarin on day1. Subjects will be administered MT-3995 Days 8 to 20. Subjects will be administered MT-3995 and warfarin on Day21. Subjects will be administered MT-3995 from Day 22 to 27.
Interventions
Eligibility Criteria
You may qualify if:
- Able and willing to provide written informed consent to participate in this study
- Healthy, free from clinically significant illness or disease
- White Caucasian male or female, aged 18 to 55 years
- Body weight ranging from 50 (females) and 60 (males) to110 kg (inclusive)
- Must have coagulation test results (including international normalised ratio \[INR\] and activated partial thromboplastin time \[aPTT\]) within the laboratory reference range at Screening.
You may not qualify if:
- Presence or history of serious adverse reaction or allergy to any medicinal product
- Known contraindication or adverse reaction to warfarin.
- Presence of Cytochrome P450 2C9 (CYP2C9) and Vitamin K epoxide reductase complex subunit 1 (VKORC1) genetic polymorphisms that are known to increase warfarin sensitivity at Screening.
- Known contraindications to heparin administration.
- Known contraindication to parenteral vitamin K administration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical research organization
Neu-Ulm, Wegenerstraße, Germany
Related Publications (1)
Nakamura T, Shimizu H, Kawaguchi A. Drug-Drug Interactions of the Nonsteroidal Mineralocorticoid Receptor Antagonist Apararenone With Midazolam, Warfarin, and Digoxin: A Phase 1 Studies in Healthy Volunteers. Clin Ther. 2020 Nov;42(11):2171-2183.e4. doi: 10.1016/j.clinthera.2020.09.002. Epub 2020 Nov 3.
PMID: 33153727DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Horst Heuer, Dr
Nuvisan GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2015
First Posted
August 24, 2015
Study Start
June 1, 2015
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
October 9, 2015
Record last verified: 2015-10