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

NCT00984880 | Completed Phase 1

• 2 other identifiers: D0510C00002Eudract number: 2008-005836-34
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Sedation; anaesthesia; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

Intravenous solution given as a single ascending bolus dose

Drug: AZD3043

2

EXPERIMENTAL

Intravenous solution given as a single ascending bolus dose followed by a single infusion

Drug: AZD3043

Interventions

AZD3043 DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Stockholm, Sweden

Location

Related Publications (1)

• Norberg A, Koch P, Kanes SJ, Bjornsson MA, Barassin S, Ahlen K, Kalman S. A Bolus and Bolus Followed by Infusion Study of AZD3043, an Investigational Intravenous Drug for Sedation and Anesthesia: Safety and Pharmacodynamics in Healthy Male and Female Volunteers. Anesth Analg. 2015 Oct;121(4):894-903. doi: 10.1213/ANE.0000000000000804.

  PMID: 26097986 DERIVED

MeSH Terms

Interventions

AZD-3043

Study Officials

• Johan Wemer

  AstraZeneca

  STUDY CHAIR

• Sigridur Kalman

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Stephen Kanes

  AstraZeneca

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 18, 2009

Record last verified: 2009-12

Locations

SE (1)