- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03680378
Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)
July 13, 2020 updated by: Allecra
A Phase I Open-Label, Single-Centre Study to Assess the Concentration of AAI101 and Cefepime in Epithelial Lining Fluid and Plasma in Healthy Volunteers
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Liverpool, United Kingdom, L69 3GL
- University of Liverpool
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
- Provision of signed and dated, written informed consent prior to any study-specific procedures.
Healthy male and female subjects aged 18 to 65 years with veins suitable for cannulation or repeated venipuncture. Female patients can participate if at least 1 of the following criteria are met:
- Are of non-childbearing potential defined as
- Permanently sterile following hysterectomy, bilateral salpingectomy, bilateral oophorectomy or confirmed tubal occlusion (not tubal ligation);
- Postmenopausal, as defined as at least 1 year post-cessation of menses (without an alternative medical cause), and per documentation provided by a medical professional;
- Postmenopausal status will be confirmed with a screening serum follicle stimulating hormone (FSH) level greater than 40 milli-international units per milliliter (mlU/mL).
- Patient has a negative urine and/or serum pregnancy test (serum β-human chorionic gonadotropin) within 1 day prior to study entry, and agrees to use highly effective contraception methods during treatment and for at least 7 days after the last dose of i.v. study therapy;
- Have a body mass index (BMI) between 18 and 32 kg/m2.
- As judged by the Investigator, all the subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements.
4.2 Exclusion criteria
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
- 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
- Subjects who have any significant condition that may preclude nasal or oral intubation with a bronchoscope as determined by the investigator
- Subjects who have any clinically significant allergy or allergic condition as determined by the investigator (with the exception of non-active hay fever)
- Subjects who have had previous adverse reactions to benzodiazepines or anaesthetic agents (lidocaine or xylocaine) including reversal agents such as flumazenil
- Subjects who have any clinically significant abnormal laboratory safety results as determined by the investigator with specific exclusions of any aspartate aminotransferase (AST) or alanine aminotransferase (ALT)upper limit of normal greater than or equal to 1.5 times upper limit of normal (ULN) at screening or day -1; total bilirubin > ULN (Gilbert's syndrome is acceptable), haemoglobin <12.0 g/dL or prothrombin time > 13 seconds (one repeat assessment is acceptable at screening)
- Subjects who have hepatitis B or C or are carriers of HBsAg or are carriers of hepatitis C virus (HCV= Ab or are positive for HIV 1/2 antibodies.
- Subjects who have a positive alcohol breath test or a positive urine drug screen ( a repeat assessment is acceptable)
- Subjects who are still participating in another clinical study or who have participated in a clinical study involving administration of an investigational product in the 3 months (or 5 half-lives, whichever is longer) prior to first dose administration
- Subjects who, in the opinion of the investigator, should not participate in this study For procedures for withdrawal of incorrectly enrolled subjects, see Section 5.3. Subjects who drop out will be replaced.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cefepime 2 gram + AAI101 1 gram
cefepime 2 grams in combination with AAI101 1 gram intravenous infusion
|
Combination of cefepime 2 gram with AAI101 1 gram
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum concentration of cefepime and AAI101 in the lung
Time Frame: Change from baseline to 2 hours, 4 hours, 6 hours and 8 hours post dose
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum concentration of cefepime and AAI101 in plasma
Time Frame: Change from baseline to 2 hours, 4 hours, 6 hours and 8 hours post dose
|
Maximum concentration of cefepime and AAI101 in plasma samples
|
Change from baseline to 2 hours, 4 hours, 6 hours and 8 hours post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
April 30, 2019
Study Completion (Actual)
April 30, 2019
Study Registration Dates
First Submitted
July 25, 2018
First Submitted That Met QC Criteria
September 20, 2018
First Posted (Actual)
September 21, 2018
Study Record Updates
Last Update Posted (Actual)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 13, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AT-103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Subjects
-
BiogenCompletedHealthy Adult Subjects | Healthy Elderly SubjectsUnited States
-
PfizerCompletedHealthy Adult Subjects and Healthy Elderly SubjectsBelgium
-
Lund UniversityCompletedHealthy Subjects | Diet, HealthySweden
-
PfizerRecruitingHealthy Subjects | Healthy ParticipantsUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedHealthy | Healthy Subjects | ImmunosuppressionUnited States
-
GEN İlaç ve Sağlık Ürünleri A.Ş.Sulfateq B.V.Recruiting
-
Bio-innova Co., LtdNot yet recruiting
-
Bio-innova Co., LtdNot yet recruiting
-
Danone NutriciaNot yet recruiting
Clinical Trials on Cefepime 2 gram
-
AllecraMedpace, Inc.CompletedUrinary Tract InfectionsHungary, Czechia, Poland, Slovakia, Ukraine
-
Hospital de Clinicas de Porto AlegreUnknownUrinary Tract Infection | Respiratory Tract InfectionBrazil
-
Norwegian University of Science and TechnologyCompleted
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedMyelodysplastic Syndromes | Breast Cancer | Primary Myelofibrosis | Multiple Myeloma | Ovarian Epithelial Cancer | Chronic Myelomonocytic Leukemia | Neutropenia | Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Splenic Marginal Zone... and other conditionsUnited States
-
GramEyeNot yet recruitingInfection, Bacterial
-
WockhardtMedpace, Inc.RecruitingAcute Pyelonephritis | Complicated Urinary Tract InfectionUnited States, China, India, Lithuania, Mexico, Peru, Poland, Bulgaria, Estonia
-
University of Kansas Medical CenterActive, not recruitingColorectal Cancer | Lynch SyndromeUnited States
-
Venatorx Pharmaceuticals, Inc.Department of Health and Human ServicesNot yet recruitingHospital-acquired Pneumonia | Ventilator-associated Pneumonia
-
Venatorx Pharmaceuticals, Inc.CompletedHealthy SubjectsUnited States
-
Venatorx Pharmaceuticals, Inc.National Institutes of Health (NIH)CompletedHealthy SubjectsUnited States