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

AstraZeneca72 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AZD3043DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Research Site

Stockholm, Sweden

Outcomes

Primary Outcomes

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

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

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

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.

Data from ClinicalTrials.gov

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