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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00918515

Enrollment

Registered

2009-06-11

Start date

2009-05-31

Completion date

2009-08-31

Last updated

2009-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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.

Interventions

DRUGAZD3043

intravenous solution given once as intravenous infusion over 30 minutes

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	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

Measure	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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026