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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Single-Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After Single Ascending Doses in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD3043


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD3043<br>Intravenous solution | Drug: AZD3043<br>* intravenous solution given once as intravenous infusion over 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, Anaesthesia, Safety, tolerability, pharmacokinetics, pharmacodynamics, healthy male volunteers