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
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Respiratory signs data (SpO2, EtCO2, PaO2, blood gases, respiratory frequency and pattern, occurrence of apnoea)
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
1
Intravenous solution given as a single ascending bolus dose
Intervention: AZD3043 (Drug)
2
Intravenous solution given as a single ascending bolus dose followed by a single infusion
Intervention: AZD3043 (Drug)
Outcomes
Primary Outcomes
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
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
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.(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)