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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00984880
First Posted: September 25, 2009
Last Update Posted: December 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]
  • 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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00984880     History of Changes
Other Study ID Numbers: D0510C00002
Eudract number: 2008-005836-34
First Submitted: September 24, 2009
First Posted: September 25, 2009
Last Update Posted: December 18, 2009
Last Verified: December 2009

Keywords provided by AstraZeneca:
Sedation
anaesthesia
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics