Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01086813
NCT01086813
Withdrawn
Phase 1

Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly (=65 Years) Healthy Volunteers

AstraZeneca0 sitesMarch 2010
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsSafetyTolerabilityPharmacokineticsSedation
InterventionsAZD3043
DrugsAZD3043

Overview

Phase
Phase 1
Intervention
AZD3043
Conditions
Safety
Sponsor
AstraZeneca
Primary Endpoint
To evaluate safety and tolerability after administration of a bolus and infusion of AZD3043
Status
Withdrawn
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly(=65 years) Healthy Volunteers

Detailed Description

Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly (=65 years) Healthy Volunteers

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
April 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Pre-anaesthesia assessment judged without remarks by the investigator.
  • •ASA physical status category 1 to 2 (up to and including 3 depending on applicable patient category)

Exclusion Criteria

  • •Lack of a normal range of enzyme activity for BuChE
  • •Known or suspected history of hypersensitivity to drugs with a similar chemical structure or class to AZD3043 (e.g., emulsion-based products like Diprivan,Intralipid), allergies to soybean or peanut products or any other drugs intended for use during th
  • •Prolonged QTcF \>450 ms or shortened QTcF \<350 ms or family history of long QT syndrome.

Arms & Interventions

1

Intervention: AZD3043

Outcomes

Primary Outcomes

To evaluate safety and tolerability after administration of a bolus and infusion of AZD3043

Time Frame: Heartrate, Bloodpressure, Telemetry, ECG, EtCO2, SPO2, BIS, Respiratory frequency every minute during a 1h session

Secondary Outcomes

  • To evaluate the PK of AZD3043 and its main metabolite (THRX-108893) in venous blood samples(During 24h)
  • To evaluate the onset, level and recovery from sedation/anaesthesia(During 24h)

Similar Trials

Completed
Phase 1
Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD3043Healthy
NCT00918515AstraZeneca53
Completed
Phase 1
Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese SubjectsHealthy Subjects
NCT04158102Nuance Pharma (shanghai) Co., Ltd20
Terminated
Phase 1
A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
NCT06560645Prelude Therapeutics42
Active, not recruiting
Phase 1
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501)Advanced Solid Tumor
NCT06421935EMD Serono Research & Development Institute, Inc.141
Recruiting
Phase 1
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) TherapyNon-Muscle-Invasive Bladder Cancer (NMIBC)
NCT06351904Ractigen Therapeutics.72