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

NCT00918515 | Completed Phase 1

• 2 other identifiers: D0510C000012007-003474-26
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, single centre, open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of intravenous AZD3043 after single ascending doses in healthy male volunteers.

Conditions

Healthy

Keywords

Sedation; Anaesthesia; Safety; tolerability; pharmacokinetics; pharmacodynamics; healthy male volunteers

Outcome Measures

Primary Outcomes (2)

• Assessment of Vital signs data, heart rate, electrocardiogram (ECG)

  The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.

• Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency, volume and pattern, occurrence of apnoea;

  The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.

Secondary Outcomes (2)

• PK parameters for AZD3043: Cmax (Css), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tlast and mean residence time in arterial and venous plasma.

  Arterial: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150 min postdose. Venous: Predose, 2, 5, 15, 29, 31, 32, 35, 37, 40, 45, 60, 75, 90, 150, 270 min, 8h, 24h postdose.

• PK parameters for the metabolite (THRX 108893): Cmax (Css), AUClast, AUC, tmax, tlast, lz and t½lz in venous plasma

  29 min, 45 min and 150 min post dose

Study Arms (1)

AZD3043

EXPERIMENTAL

Intravenous solution

Drug: AZD3043

Interventions

AZD3043 DRUG

intravenous solution given once as intravenous infusion over 30 minutes

AZD3043

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged 18 to 45 years with suitable veins for cannulation or repeated venepuncture
• Pre-dose assessment judged without remarks by the investigator
• Have a Body Mass Index (BMI) between 19 and 30 kg/m2 and weight at least 50kg and no more than 100kg

You may not qualify if:

• After adequate time (at least 15 minutes) of rest in supine position, abnormal vital signs defined as any of the following:·
• Systolic blood pressure (BP) \>140 mm Hg.·
• Diastolic BP \>90 mm Hg.
• Heart rate \<=55 or \>85 beats per minute
• Subjects with compromised airway or respiratory function as evidenced by the presence of Class 3 or 4 Airway, Sleep Apnoea, Neck circumference \> 16.5 inches (42 cm), Asthma, Active or recent (2 weeks) respiratory infection, or known chronic respiratory infection, or known chronic respirator
• Lack of a normal phenotype for butyrylcholinesterase (pseudo-cholinesterase)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Stockholm, Sweden

Location

MeSH Terms

Interventions

AZD-3043

Study Officials

• Johan Wemer

  AstraZeneca R&D Södertälje

  STUDY CHAIR

• Sigridur Kalman

  Department of Clinical Science Intervention and technology, CLINTECThe department of Anaesthosiology and Intensive care, Karolinska University hospital, Huddinge,141 86 Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 28, 2009

Record last verified: 2009-08

Locations

SE (1)