Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)

NCT03680378 | Completed Phase 1

• 1 other identifier: AT-103
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to measure and compare the concentration of AAI101 and cefepime in bronchial epithelial lining fluid (ELF) and plasma following administration of cefepime/AAI101 combination in healthy subjects.

Conditions

Healthy Subjects

Keywords

bronchial epithelial lining fluid

Outcome Measures

Primary Outcomes (1)

• Maximum concentration of cefepime and AAI101 in the lung

  Maximum concentration of cefepime and AAI101 in Bronchoalveolar lavage (BAL) samples

  Change from baseline to 2 hours, 4 hours, 6 hours and 8 hours post dose

Secondary Outcomes (1)

• Maximum concentration of cefepime and AAI101 in plasma

  Change from baseline to 2 hours, 4 hours, 6 hours and 8 hours post dose

Study Arms (1)

Cefepime 2 gram + AAI101 1 gram

EXPERIMENTAL

cefepime 2 grams in combination with AAI101 1 gram intravenous infusion

Drug: Cefepime 2 gram

Interventions

Cefepime 2 gram DRUG

Combination of cefepime 2 gram with AAI101 1 gram

Also known as: AAI101

Cefepime 2 gram + AAI101 1 gram

Eligibility Criteria

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

You may not qualify if:

• Male subjects who do not agree to follow contraception restrictions.
• Female subjects who are pregnant or currently lactating
• Female subjects who are of child bearing potential who do not agree to follow contraception restrictions as detailed in section 5.1.10.
• Donated blood in the 3 months prior to screening, plasma in the 7 days prior to screening, platelets in the 6 weeks prior to screening
• Consume more than 28 units of alcohol per week if male, or 21 units of alcohol per week if female or any significant history of alcohol / substance misuse as determined by the investigator
• Unwilling to abstain from vigorous exercise for 48 hours prior to any study visit
• Unwilling to abstain from alcohol for 48 hours prior to any study visit
• Used cigarettes or vapor e-cigarettes, cigars or other nicotine-containing products (with the exception of nicotine replacement products not covered above) within 3 months before bronchoscopy or have a smoking history greater than 10 pack years.
• Received any medication, including St John's Wort, known to chronically alter drug absorption or elimination within 30 days prior to first dose administration unless in the opinion of the investigator it will not interfere with study procedures or compromise safety
• Received any prescribed systemic or topical medication within 14 days prior to the first dose administration (with the exception of the oral contraceptive pill)
• Received any non-prescribed systemic or topical medication, herbal remedy or vitamin / mineral supplementation within 14 days prior to the first dose administration (with the exception of paracetamol).
• Subjects who have any abnormality of vital signs prior to the first dose administration that, in the opinion of the investigator, would increase the risk of participating in the study
• Subjects who have any clinically significant abnormal physical examination finding
• Subjects who have any clinically significant 12 lead ECG abnormality that, in the opinion of the investigator, would increase the risk of participating in the study
• Subjects who have, or have any history of, any clinically significant cardiovascular, respiratory, gastrointestinal, neurological, psychiatric, metabolic, endocrine, renal, hepatic, haematological or other major disorder as determined by the investigator

Sponsors & Collaborators

• Allecra: lead

Study Sites (1)

University of Liverpool

Liverpool, L69 3GL, United Kingdom

Location

MeSH Terms

Interventions

enmetazobactam

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: September 21, 2018
• Study Start: July 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)