A Preliminary Drug Drug Interaction Study With TA-8995

• Sponsor: Xention Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02124954
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetic Interactions	Drug: TA-8995; Drug: Midazolam; Drug: Digoxin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• 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
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Plasma concentrations of TA-8995, midazolam and digoxin [Over 16 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Healthy male subjects

Exclusion Criteria

• Receiving any other drug therapy

• Clinically significant medical history

• Abnormal laboratory results or ECGs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance	Leeds		United Kingdom	LS2 9LH

Sponsors and Collaborators

• Xention Ltd

Investigators

• Principal Investigator: Ashley Brooks, Covance

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xention Ltd
• ClinicalTrials.gov Identifier: NCT02124954
• Other Study ID Numbers: TA-8995-05
• First Posted: Apr 28, 2014
• Last Update Posted: Oct 3, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Digoxin; Midazolam

Study Results

No Results Posted as of Oct 3, 2016