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OpenTrials
Completed

NCT Number: NCT00984880

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

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).

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AZD3043

Drug

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

Primary outcomes

  1. Assessment of vital signs data, heart rate, ECG

    Time frame: The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043

  2. Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency and pattern, occurrence of apnoea)

    Time frame: The measure will be taken between -20 to 120 min relative to stop of administration of AZD3043

Secondary outcomes

  1. 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.

    Time frame: 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

  2. 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.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Study completion
2009
First posted
Sep 25, 2009
Registry last updated
Dec 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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