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Teicoplanin Sandoz and solvent for or infusion

Phase 1

Cystic Fibrosis | Small molecule | Respiratory |Catalent, Inc.|Trials Updated: Dec 9, 2020

Success Probability

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Teicoplanin Sandoz and solvent for or infusion clinical trials

Teicoplanin Sandoz and solvent for or infusion · 1 trial · 1 indication

Phase 1 1
NCT04176328Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis PatientsCystic Fibrosis
COMPLETED12 Analytics
PHASE1COMPLETED
Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients
Cystic Fibrosis
NCT0417632812
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Study Endpoints

Primary Endpoints

Concentration of Teicoplanin in the sputum of CF patients treated with inhaled Teicoplanin.
Change occurring from pre-inhalation (0 hours) to the following time points: after 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 30 hours, 48 hours from each inhalation.

Measurement of the concentration (expressed as mg/L) of Teicoplanin in the sputum of patients suffering of Cystic Fibrosis after a single inhalation of 150 mg at scheduled time points after first inhalation: 0 hours, 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 30 hours, 48 hours. In case a value of sputum AUC0-12 h above 300 μg/mL\*h will not be achieved with the first dosage inhalation of Teicoplanin, up to two additional inhalations with different dosages will be foreseen and the same time points will be measured for subsequent inhalations. In addition, the inhalation of Teicoplanin with the maximum (300 mg) dosage foreseen by study protocol is expected for all patients aiming to confirm the optimal intermediate dosage tested during the dose-escalation process.

Secondary Endpoints

Concentration of Teicoplanin in the blood of CF patients treated with inhaled Teicoplanin.
Change occurring from pre-inhalation (0 hours) to the following time points: after 0.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours from each inhalation.
Concentration of Teicoplanin in the urine of CF patients treated with inhaled Teicoplanin.
Change occurring from pre-inhalation (0 hours) to the following time points: during the intervals 0-4 hours, 4-12 hours, 12-24 hours from each inhalation + after 48 hours from inhalation.
Comparison between concentrations of Teicoplanin in the sputum, blood and urine of CF patients treated with inhaled Teicoplanin.
During each inhalation visit throughout study period, an average of 3 months per patient.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cystic Fibrosis patients treated with TeicoplaninEXPERIMENTALHospitalized male and female patients aged ≥ 18 years, suffering of Cystic Fibrosis.

Interventions

NameTypeDescription
Teicoplanin Sandoz 200 mg powder and solvent for solution for injection or infusion or oral solution.DRUGTeicoplanin Sandoz administered by inhalation (aerosol).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

INCLUSION CRITERIA: 1. Male or female patients, aged ≥18 years with a confirmed diagnosis of cystic fibrosis. 2. Patients with body weight ≥50 kg and ≤100 kg 3. Patients with body mass index (BMI) between 18.0 and 30 kg/m2. 4. Patients with FEV1 \> 50% of predicted. 5. Patients with regular mucus p...

Countries:Italy
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Competitive Landscape -Cystic Fibrosis 20 trials

Top 6 of 7 competitors

CompanyTickerTrialsLead PhaseDrugs
Vertex Pharmaceuticals IncorporatedVRTX8PHASE3Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272
BiomX Inc.PHGE1PHASE2BX004
4D Molecular Therapeutics, Inc.FDMT1PHASE24D-710
Arcturus Therapeutics Holdings, Inc.ARCT1PHASE2ARCT-032
Krystal Biotech, Inc.KRYS1PHASE1KB407
Roivant Sciences Ltd.ROIV1PHASE1SP-101
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