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Completed

NCT Number: NCT02124954

A Preliminary Drug Drug Interaction Study With TA-8995

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).

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Key information

Conditions

Pharmacokinetic Interactions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects

Exclusion criteria

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

Treatment and study plan

TA-8995

Drug

midazolam

Drug

Digoxin

Drug

Primary outcomes

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

    Time frame: Over 16 days

Sponsors and collaborators

Lead sponsor

Xention Ltd

Industry

Registry information

Official study title

A Phase I, Open Label Study to Assess the Effects of TA-8995 on the Pharmacokinetics of Midazolam and Digoxin in Healthy Male Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 28, 2014
Registry last updated
Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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