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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984880
• Other study ID #: D0510C00002
• Secondary ID: Eudract number:
• Status: Completed
• Phase: Phase 1
• First received: September 24, 2009
• Last updated: December 17, 2009
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: December 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD3043
Intravenous solution given as bolus dose (part A) and as bolus dose followed by infusion (part B)

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of vital signs data, heart rate, ECG		The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043	Yes
Primary	Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency and pattern, occurrence of apnoea)		The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043	Yes
Secondary	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.		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	No
Secondary	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.		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	No