Renal Impairment Pharmacokinetics (PK) Trial of Afabicin
ConditionRenal Impairment
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorDebiopharm International SA
About this trial
The primary purpose of this study is to assess the effect of renal impairment on the PK of afabicin desphosphono after a single oral 80 milligrams (mg) or intravenous (IV) 55 mg dose of afabicin.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed and dated written informed consent obtained before undertaking any trial-specific procedures.
Body Mass Index (BMI): 18.5 to 35.0 kilograms per square meter (kg/m²), inclusive, at screening.
Nonsmoker (confirmed by urine cotinine <500 nanograms per milliliter (ng/mL)) and have not used nicotine or nicotine containing products for the last month before screening.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures.
Disqualifiers
Any clinically significant symptoms of an infectious illness (bacterial, viral or parasitic) within 2 weeks prior to first dosing or a history of recurrent infections (≥3 infections requiring medical intervention in the 6 months prior to ICF signature).
History of chronic drug or alcohol abuse in the last 4 years.
A positive result in the alcohol and/or urine drug abuse evaluations at screening or admission on Day -1, unless the result is attributable to a prescribed medication used to treat comorbidities associated with chronic kidney disease or another stable condition.
History of investigational medication use within 3 months or 5 half-lives of the drug (whichever is longer) prior to administration the trial drug.
Trial design
Design model
Parallel
Treatments tested in this trial
Afabicin Oral
DrugTablet
Afabicin IV
DrugIV infusion
Treatment groups
60 Participants
are divided into 5 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Experimental treatment 1 intervention
Group E: Group 5Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Afabicin Desphosphono
Time frame
From predose and at multiple timepoints (up to Day 5) post doseSecondary outcomes
1
Maximum Observed Plasma Concentration (Cmax) of Afabicin Desphosphono
Time frame
From predose and at multiple timepoints (up to Day 5) post dose2
Area Under the Plasma Concentration-Time Curve to the Last Quantifiable Concentration (AUClast) of Afabicin Desphosphono
Time frame
From predose and at multiple timepoints (up to Day 5) post dose3
Time of Maximum Observed Plasma Concentration (tmax) of Afabicin Desphosphono
Time frame
From predose and at multiple timepoints (up to Day 5) post dose4
Apparent Plasma Terminal Elimination Half-Life (t1/2) of Afabicin Desphosphono
Time frame
From predose and at multiple timepoints (up to Day 5) post doseSponsors and contacts
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Source ClinicalTrials.gov
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