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Trial record 61 of 2230 for:    Recruiting, Not yet recruiting, Available Studies | Renal

Pharmacokinetics of Cefepime and AAI101 in Subjects With Renal Insufficiency and Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03680352
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Allecra

Brief Summary:

This is a Phase 1, multi-center, open-label, PK and safety study of a single dose of AAI101 in combination with cefepime in male and female subjects with mild renal impairment (Group 1, n = 6), moderate renal impairment (Group 2, n = 6), severe renal impairment (Group 3, n = 6), ESRD requiring dialysis (Group 4, n = 6), and normal renal function (Group 5, n = 6) as defined using the estimated value for creatinine clearance (CLcr) at Screening.

The study consists of a 28-day screening period, followed by a single dose administration of AAI101 in combination with cefepime antibiotic on Day 1, an in house period (assessment period) and follow-up visit. All subjects will be confined to the study site from Day -1 (the day before dosing) until the morning of Day 3. The follow-up visits will occur on Day 7 (±2 days), on Day 14 (±2 days), and on Day 30 (±2 days), if the results of the safety hepatic assessments are abnormal on Day 14 (±2 days).

Group 4 (ESRD requiring dialysis) will have 2 in-house periods (separated by at least 7 days), and will receive the single doses of AAI101 in combination with cefepime antibiotic once after dialysis and once before dialysis. The follow-up visit for Group 4 will occur on Day 7 (±2 days), on Day 14 (±2 days), and on Day 30 (±2 days), if the results of the safety hepatic assessments are abnormal on Day 14 (±2 days), counting from Day 1 of the second period.


Condition or disease Intervention/treatment Phase
PK in Patients With Various Degrees of Renal Impairment Drug: cefepime/AAI101 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase 1, Open-label, Parallel Group, Single-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AAI101 With Cefepime in Subjects With Varying Degrees of Renal Function
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cefepime/AAI101 combination
Investigational drug
Drug: cefepime/AAI101
Fixed dose combination of cefepime and AAI101




Primary Outcome Measures :
  1. The maximum plasma concentration (Cmax) of cefepime and AAI101 [ Time Frame: Up to 48 hours post-dose ]
    Cmax will be compared before and after administration of a single dose of cefepime/AAI101

  2. AUC0-inf: area under the concentration-time curve (AUC) from time 0 extrapolated to infinity of cefepime and AAI101 [ Time Frame: Up to 48 hours post-dose ]
    AUC0-inf will be compared before and after administration of a single dose of cefepime/AAI101


Secondary Outcome Measures :
  1. The number of volunteers with adverse events as a measure of safety and tolerability [ Time Frame: Up to 96 hours post-dose ]
    Assessments will be made via recording of AEs.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Main Inclusion Criteria

  • Adult male or female subjects age 18 to 70 years, inclusive
  • BMI 18.0 35.0 kg/m2, inclusive, where BMI (kg/m2) = body weight (kg) / height2 (m2) Subjects with Renal Impairment (in addition)
  • Stable renal impairment, defined as no clinically significant change in disease status, as judged by the Investigator Healthy Subjects (in addition)
  • Subjects with normal renal function as evidenced by CLcr
  • Judged to be in good health in the opinion of the Investigator on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality OR Subject has a stable disease (e.g., hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680352


Locations
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Czechia
Pharmaceutical Research Associates CZ, s.r.o. Recruiting
Praha, Jankovcova, Czechia, 170 00
Contact: Felix Muehr-Wilkenshoff, MD    +49 30 32304 9040    muehrfelix@prahs.com   
Principal Investigator: Lucia Martinkovicova, MD         
Hungary
PRA Magyarország Kft Fázis I-es Klinikai Farmakológiai Vizsgálóhely Recruiting
Budapest, Rottenbiller Utca 13, Hungary, HJ-1077
Contact: Felix Muehr-Wilkenshoff, MD    +49 30 32304 9040    muehrfelix@prahs.com   
Principal Investigator: Istvan Kiss, MD         
Sponsors and Collaborators
Allecra

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Responsible Party: Allecra
ClinicalTrials.gov Identifier: NCT03680352     History of Changes
Other Study ID Numbers: AT-102
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cefepime
Anti-Bacterial Agents
Anti-Infective Agents