Clinical trial NCT04973826: Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.
Official title: A PHASE I, SINGLE CENTER, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM ADMINISTERED AS SINGLE AND REPEATED INTRAVENOUS DOSES IN HEALTHY CHINESE PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: no clinically relevant abnormalities
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A Phase 1, single center, single arm, open-label study to assess the PK, safety and tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy Chinese participants.


Eligibility criteria: Inclusion Criteria:

* Healthy Chinese male and female participants
* No clinical relevant abnormalities
* willing and able to comply with all study procedures
* BMI:17.5-30.5
* Sign informed consent

Exclusion Criteria:

* Any clinical significant illness
* History of alcohol abuse
* Use within 14 days prior the first study dose
* CL\>80ml/min
* Abnormal vital signs, such 12-ECG, blood pressure and pulse rate
* Blood donation within 60days
* History of HIV, HBsAg, HBcAb, HCVAb
* Other medical or psychiatric may inappropriate for the study

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Aztreonam
timeFrame: Post dose on day 1 and day 4
measure: Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Avibactam
timeFrame: Post dose on day 1 and day 4
measure: Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Aztreonam
timeFrame: Post dose on day 1
measure: Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Avibactam
timeFrame: Post dose on day 1
measure: Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Aztreonam
timeFrame: Post dose on day 1 and day 4
measure: Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Avibactam
timeFrame: Post dose on day 1 and day 4
measure: Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Aztreonam
timeFrame: Post dose on day 1 and day 4
measure: Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Avibactam
timeFrame: Post dose on day 1 and day 4
measure: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Aztreonam
timeFrame: Post dose on day 1 and day 4
measure: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Avibactam
timeFrame: Post dose on day 1 and day 4
measure: Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Aztreonam
timeFrame: Post dose on day 4
measure: Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Avibactam
timeFrame: Post dose on day 4
measure: Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Aztreonam
timeFrame: Post dose on day 4
measure: Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Avibactam
timeFrame: Post dose on day 4
measure: Renal Clearance (CLr) on Day 1 & 4 of Aztreonam
timeFrame: Post dose on day 1 and day 4
measure: Renal Clearance (CLr) on Day 1 & 4 of Avibactam
timeFrame: Post dose on day 1 and day 4
Secondary outcomes:
measure: Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Aztreonam
timeFrame: Post dose on day 1 and day 4
measure: Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Avibactam
timeFrame: Post dose on day 1 and day 4
measure: Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Aztreonam
timeFrame: Post dose on day 1 and day 4
measure: Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Avibactam
timeFrame: Post dose on day 1 and day 4
measure: Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Aztreonam
timeFrame: Post dose on day 1 and day 4
measure: Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Avibactam
timeFrame: Post dose on day 1 and day 4
measure: Clearance (CL) on Day 1 & 4 of Aztreonam
timeFrame: Post dose on day 1 and day 4
measure: Clearance (CL) on Day 1 & 4 of Avibactam
timeFrame: Post dose on day 1 and day 4
measure: Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Aztreonam
timeFrame: Post dose on day 1 and day 4
measure: Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Avibactam
timeFrame: Post dose on day 1 and day 4
measure: Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Aztreonam
timeFrame: Post dose on day 4
measure: Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Avibactam
timeFrame: Post dose on day 4
measure: Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Aztreonam
timeFrame: Post dose on day 4
measure: Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Avibactam
timeFrame: Post dose on day 4
measure: Number of Participants With an Adverse Event (AE)
timeFrame: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
measure: Number of Participants With Abnormal Vital Signs
timeFrame: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
measure: Number of Participants With Abnormal Electrocardiograms (ECGs)
timeFrame: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
measure: Number of Participants With Abnormal Laboratory Assessments
timeFrame: From the first dose of study treatment to the last dose of study treatment date +28 +7 days (up to 2 months)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: