NCT02124954

Brief Summary

A study in healthy males to look at how multiple doses of TA-8995 affect blood levels and rate of removal of other drugs, using single doses of digoxin and midazolam as examples, to see if there are any potential drug interactions that might affect patients in future studies. The study will examine whether co-administration of TA-8995 affects the pharmacokinetics of digoxin and midazolam measured by area under the curve (AUC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2014

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

April 17, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

April 17, 2014

Last Update Submit

September 30, 2016

Conditions

Pharmacokinetic Interactions

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of TA-8995, midazolam and digoxin

    Over 16 days

Study Arms (2)

Digoxin with/without TA-8995

EXPERIMENTAL

Digoxin with/without TA-8995

Drug: TA-8995Drug: Digoxin

Midazolam with/without TA-8995

EXPERIMENTAL

Midazolam with/without TA-8995

Drug: TA-8995Drug: Midazolam

Interventions

TA-8995DRUG
Digoxin with/without TA-8995Midazolam with/without TA-8995
MidazolamDRUG
Midazolam with/without TA-8995
DigoxinDRUG
Digoxin with/without TA-8995

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects

You may not qualify if:

  • Receiving any other drug therapy
  • Clinically significant medical history
  • Abnormal laboratory results or ECGs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

TA-8995MidazolamDigoxin

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDigitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Ashley Brooks

    Covance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 28, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 3, 2016

Record last verified: 2016-09

Locations

GB(1)