NCT02779348

Brief Summary

The purpose of this study is to determine whether multiple-dose administration of nebicapone affects the pharmacokinetics of warfarin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

May 18, 2016

Last Update Submit

August 23, 2017

Conditions

Healthy

Keywords

NebicaponeWarfarin

Outcome Measures

Primary Outcomes (10)

  • Mean Cmax of S-warfarin

    Maximum observed plasma drug concentration (Cmax)

    before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose

  • Mean tmax of S-warfarin

    Time of occurrence of Cmax (tmax)

    before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose

  • Mean AUC0-144 of S-warfarin

    Area under the plasma concentration-time curve (AUC) from time zero to 144 h post-warfarin dose (AUC0-144), calculated by the linear trapezoidal rule

    before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose

  • Mean λz of S-warfarin

    Apparent terminal rate constant calculated by log-linear regression of the terminal segment of the concentration versus time curve (λz)

    before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose

  • Mean t1/2 of S-warfarin

    Apparent terminal half-life, calculated from ln 2/λz (t1/2).

    before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose

  • Mean Cmax of R-warfarin

    Maximum observed plasma drug concentration (Cmax)

    before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose

  • Mean tmax of R-warfarin

    Time of occurrence of Cmax (tmax)

    before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose

  • Mean AUC0-144 of R-warfarin

    Area under the plasma concentration-time curve (AUC) from time zero to 144 h post-warfarin dose (AUC0-144), calculated by the linear trapezoidal rule

    before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose

  • Mean λz of R-warfarin

    Apparent terminal rate constant calculated by log-linear regression of the terminal segment of the concentration versus time curve (λz)

    before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose

  • Mean t1/2 of R-warfarin

    Apparent terminal half-life, calculated from ln 2/λz (t1/2).

    before the warfarin dose, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 hours post-warfarin dose

Study Arms (2)

Nebicapone plus warfarin

EXPERIMENTAL

BIA 3-202 200 mg tid + Warfarin 25 mg

Drug: BIA 3-202Drug: warfarin

Warfarin

EXPERIMENTAL

Warfarin 25 mg

Drug: warfarin

Interventions

BIA 3-202DRUG

Nebicapone tablets 200 mg

Also known as: Nebicapone
Nebicapone plus warfarin
warfarinDRUG

Varfine® 5 mg (warfarin 5 mg) tablets

Nebicapone plus warfarinWarfarin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female subjects aged between 18 and 45 years, inclusive.
  • Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
  • Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
  • Clinical laboratory test results clinically acceptable at screening and admission to first treatment period.
  • Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
  • Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
  • Non-smokers or who smoked ≤ 10 cigarettes or equivalent per day.
  • Able and willing to give written informed consent.
  • (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
  • (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.

You may not qualify if:

  • Clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
  • Clinically relevant surgical history.
  • Personal or family history of haemostatic disorder.
  • Personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis.
  • Any abnormality in the coagulation tests.
  • Any abnormality in the liver function tests.
  • A history of relevant atopy or drug hypersensitivity.
  • History of alcoholism or drug abuse.
  • Consumed more than 14 units of alcohol a week.
  • Significant infection or known inflammatory process at screening or admission to each treatment period.
  • Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
  • Had used medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.
  • Had previously received BIA 3-202.
  • Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.
  • Had participated in more than 2 clinical trials within the 12 months prior to screening.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Pharmacology Unit (UFH),

S. Mamede Do Coronado, 4745-457, Portugal

Location

MeSH Terms

Interventions

nebicaponeWarfarin

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 20, 2016

Study Start

September 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 24, 2017

Record last verified: 2017-08

Locations

PT(1)