A Preliminary Drug Drug Interaction Study With TA-8995

Pharmacokinetic Interactions Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124954
• Other study ID #: TA-8995-05
• Status: Completed
• Phase: Phase 1
• First received: April 17, 2014
• Last updated: September 30, 2016
• Start date: May 2014
• Est. completion date: July 2014

Study information

• Verified date: September 2016
• Source: Xention Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria

• Healthy male subjects

Exclusion Criteria

• Receiving any other drug therapy

• Clinically significant medical history

• Abnormal laboratory results or ECGs

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pharmacokinetic Interactions

Intervention

Drug:
• TA-8995

• Midazolam

• Digoxin

Locations

Country	Name	City	State
United Kingdom	Covance	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Xention Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of TA-8995, midazolam and digoxin		Over 16 days	No