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

Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After a Single Ascending Bolus Dose, and a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00984880

Enrollment

Registered

2009-09-25

Start date

2009-09-30

Completion date

2009-12-31

Last updated

2009-12-18

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

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).

Interventions

DRUGAZD3043

Intravenous solution given as bolus dose (part A) and as bolus dose followed by infusion (part B)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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
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

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026