CClinicalTrials.gg
CompletedNCT02124954Updated Oct 3, 2016

A Preliminary Drug Drug Interaction Study With TA-8995

A Phase 1 interventional study of TA-8995 and Midazolam in Pharmacokinetic Interactions, sponsored by Xention Ltd. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-03.

Sponsored by Xention Ltd · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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).

02

Conditions studied

  • Pharmacokinetic Interactions
03

In context

Lead sponsor

Xention Ltd is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male subjects

Exclusion criteria

Exclusion Criteria

  • Receiving any other drug therapy
  • Clinically significant medical history
  • Abnormal laboratory results or ECGs
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Digoxin with/without TA-8995

    Digoxin with/without TA-8995

    Drug: TA-8995 · Drug: Digoxin

  • Experimental
    Midazolam with/without TA-8995

    Midazolam with/without TA-8995

    Drug: TA-8995 · Drug: Midazolam

Interventions

  • DrugTA-8995
  • DrugMidazolam
  • DrugDigoxin
06

What researchers measure

Primary outcomes

  1. Plasma concentrations of TA-8995, midazolam and digoxin

    Time frame: Over 16 days

07

Study locations

1 site
  • Covance
    Leeds, LS2 9LH, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02124954
Lead sponsor
Xention Ltd
Responsible party
Sponsor
First posted
Apr 28, 2014
Start date
May 2014
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Oct 3, 2016

Study contacts

Ashley Brooks
principal investigator · Covance

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion