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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD3043

• Registration Number: NCT00984880
• Lead Sponsor: AstraZeneca

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Status Verified: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2009-12-17
• Last Update Posted: 2009-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	AZD3043	Intravenous solution given as a single ascending bolus dose followed by a single infusion
1	AZD3043	Intravenous solution given as a single ascending bolus dose

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden