Clinical trial NCT00918515: Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD3043
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Sedation
Anaesthesia
Safety
tolerability
pharmacokinetics
pharmacodynamics
healthy male volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 53
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of Vital signs data, heart rate, electrocardiogram (ECG)
timeFrame: The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.
measure: Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency, volume and pattern, occurrence of apnoea;
timeFrame: The measure will be taken between -20 to 150 min relative to start of administration of AZD3043.
Secondary outcomes:
measure: PK parameters for AZD3043: Cmax (Css), AUClast, AUC, lz, t½lz, CL, Vc, Vss, Vz, tlast and mean residence time in arterial and venous plasma.
timeFrame: 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.
measure: PK parameters for the metabolite (THRX 108893): Cmax (Css), AUClast, AUC, tmax, tlast, lz and t½lz in venous plasma
timeFrame: 29 min, 45 min and 150 min post dose
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Södertälje
name: Johan Wemer
role: STUDY_CHAIR
affiliation: Department of Clinical Science Intervention and technology, CLINTECThe department of Anaesthosiology and Intensive care, Karolinska University hospital, Huddinge,141 86 Stockholm, Sweden
name: Sigridur Kalman
role: PRINCIPAL_INVESTIGATOR
References: