Pharmacokinetics and safety of intratympanic adenosine receptor ligands

Phase 1

• Conditions: Hearing loss; Ear - Deafness

• Registration Number: ACTRN12621000749808
• Lead Sponsor: Eisdell Moore Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients undergoing elective translabyrithine resection of vestibular schwannoma

Exclusion Criteria

i. Unstable cardiac disease (Arrhythmias, recent MI/stent)
ii. Renal impairment (Creatinine >100 umol/L)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events as assessed by patient medical records. [48 hours post intervention]

Secondary Outcome Measures

Name	Time	Method
Establishing the pharmacokinetics of adenosine ligands delivered intratympanically, in particular its absorption through the round window into the perilymph<br>We will measure Cmax, Tmax, AUC, clearance and T1/2 for plasma and perilymph[Baseline, 30, 60, 120, 240 minutes post intervention]