Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00984880
First received: September 24, 2009
Last updated: December 17, 2009
Last verified: December 2009
  Purpose

The primary purpose of this study is to assess the safety and tolerability of AZD3043 following administration of single ascending bolus doses (Part A) and single ascending bolus doses followed by infusion (Part B).


Condition Intervention Phase
Healthy
Drug: AZD3043
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After a Single Ascending Bolus Dose, and a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Healthy Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Assessment of vital signs data, heart rate, ECG [ Time Frame: The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043 ] [ Designated as safety issue: Yes ]
  • Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency and pattern, occurrence of apnoea) [ Time Frame: The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK parameters for AZD3043: Cmax (in part B: bolus Cmax and infusion Cmax), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tmax, tlast and MRT arterial and venous plasma. [ Time Frame: Part A: Arterial: Predose and continously up to 120 min after start of dosing. Part B: Arterial: Predose and continously up to 150 min after start of dosing. Venous: Predose and continously up to 24 h after start of dosing ] [ Designated as safety issue: No ]
  • PK parameters for the metabolite (THRX 108893): Cmax (in part B: bolus Cmax and infusion Cmax), AUClast, AUC, tmax, tlast, lz and t½lz in arterial and venous plasma. [ Time Frame: Part A: Arterial: Predose and continously up to 120 min after start of dosing. Part B: Arterial: Predose and continously up to 150 min after start of dosing. Venous: Predose and continously up to 24 h after start of dosing ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: September 2009
Study Completion Date: December 2009
Arms Assigned Interventions
Experimental: 1
Intravenous solution given as a single ascending bolus dose
Drug: AZD3043
Intravenous solution given as bolus dose (part A) and as bolus dose followed by infusion (part B)
Experimental: 2
Intravenous solution given as a single ascending bolus dose followed by a single infusion
Drug: AZD3043
Intravenous solution given as bolus dose (part A) and as bolus dose followed by infusion (part B)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with suitable veins for cannulation or repeated venepuncture
  • Pre-dose assessment judged without remarks by the investigator
  • Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

  • Abnormal vital signs, after 15 minutes supine rest, defined as any of the following:
  • Systolic blood pressure >140 mm Hg
  • Diastolic blood pressure >90 mm Hg
  • Heart rate ≤45 or >85 beats per minute
  • Lack of normal phenotype for BuChE (Butyrylcholinesterase)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984880

Locations
Sweden
Research Site
Stockholm, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Johan Wemer AstraZeneca
Principal Investigator: Sigridur Kalman Karolinska University Hospital
Study Director: Stephen Kanes AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00984880     History of Changes
Other Study ID Numbers: D0510C00002, Eudract number: 2008-005836-34
Study First Received: September 24, 2009
Last Updated: December 17, 2009
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Sedation
anaesthesia
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics

ClinicalTrials.gov processed this record on July 23, 2014