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NXL104

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 1, 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

NXL104 · 3 trials · 3 indications

Phase 1 3
NCT01448395Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104Healthy
COMPLETED6 Analytics
NCT01290900A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male VolunteersHealthy Male Volunteers
COMPLETED54 Analytics
NCT01291602A Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese SubjectsHealthy Male and Female Japanese Volunteers
COMPLETED15 Analytics
PHASE1COMPLETED
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104
Healthy
NCT014483956
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PHASE1COMPLETED
A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
Healthy Male Volunteers
NCT0129090054
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PHASE1COMPLETED
A Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects
Healthy Male and Female Japanese Volunteers
NCT0129160215
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Study Endpoints

Primary Endpoints

Mass balance after a single intravenous (IV) dose of [14C]NXL104 as generated from recovery of total radioactivity excreted in urine
168 hours
Routes of [14C]NXL104 metabolism and excretion measured through total radioactivity concentrations in urine
168 hours
Whole blood and plasma partitioning of total radioactivity through measurement of total radioactivy levels in blood
168 hours
Mass balance after a single intravenous (IV) dose of [14C]NXL104 as generated from recovery of total radioactivity excreted in faeces
168 hours
Routes of [14C]NXL104 metabolism and excretion measured through total radioactivity concentrations in faeces
168 hours
To investigate the effect of supratherapeutic doses of ceftazidime NXL104 (CAZ104) or ceftaroline fosamil NXL104 (CXL104) on the QT interval (QTcF).
12-lead dECG will be performed pre-dose
Adverse events will be monitored as a measure of safety and tolerability
A range of 12 days
Vital signs, physical examinations, clinical laboratory tests, 12 lead electrocardiogram (ECG) and digital ECG will be assessed as a measure of safety and tolerability
A range of 12 days

Secondary Endpoints

IV pharmacokinetics (PK) of [14C]NXL104 through calculation of Cmax, Tmax, AUC0-infinity, T1/2, MRT, terminal elimination rate constant, amount of NXL104 (Ae), % excreted, will be calculated from NXL104 concentrations in urine and faeces
Predose, 0.25, 0.5, 1,1.25,1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168 hours
Metabolites of [14C]NXL104 in plasma, whole blood, urine and faeces calculated from plasma,urine and faces concentration levels.Identification of major metabolites in plasma,urine and faeces where possible
Whole blood:Predose, 0.25, 0.5, 1,1.25,1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168 hoursUrine and Faeces samples Predose-144 hours
Safety and tolerability of NXL104 as number of patients with adverse events and assessment of Electrocardiogram (ECG) and vital signs results
Electrocardiogram (ECG) recordings at Screening Pre-dose, 1 ,24 and 168 hoursContinuous ECG monitoring 0-1 hourVital signs measurements screening pre-dose, 0.5, 1, 2, 24 and 168 hours
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
CXL104EXPERIMENTAL2000 mg NXL104 + 1500 mg Ceftaroline (IV)
CAZ104EXPERIMENTALPlacebo Infusion (saline) + 2000 mg NXL104 + 3000 mg Ceftazidime (IV)
MoxifloxacinACTIVE_COMPARATORMoxifloxacin 400mg (1 tablet)
PlaceboPLACEBO_COMPARATORPlacebo Infusion (saline)
NXL104EXPERIMENTALSix Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104
Ceftazidime NXL104 (CAZ104)EXPERIMENTALSix Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime

Interventions

NameTypeDescription
[14C]NXL104DRUG500mg/100mL intravenous solution
NXL104DRUGIV Solution
CeftarolineDRUGIV Solution
Placebo InfusionDRUGIV Saline
CeftazidimeDRUGIV Solution
MoxifloxacinDRUGTablet (1)
CAZ104DRUGIV Solution
PlaceboDRUGIV saline
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Eligibility Criteria

Age Range30 Years to 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * Healthy male subjects aged 30-65 years inclusive. * Male subjects should be willing to use an adequate method of contraception (as defined in Section 5.1) from the day of dosing until 3 months after dosing...

Countries:United KingdomUnited States
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Frequently asked questions about NXL104

What is NXL104 used for?

NXL104 is an investigational small molecule being studied for use in complicated urinary tract infections. It has been evaluated in clinical trials involving healthy volunteers and patients with this infection, typically in combination with ceftazidime or ceftaroline fosamil.

Who makes NXL104?

NXL104 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company has sponsored clinical trials to evaluate the safety, tolerability, and efficacy of this investigational drug.

What phase is NXL104 in?

NXL104 is in clinical development, with completed trials in Phase 1 and Phase 2. It is not approved by the FDA and remains investigational. The most advanced completed study was a Phase 2 trial in patients with complicated urinary tract infections.

What clinical trials is NXL104 in?

NXL104 has been studied in several completed trials, including NCT00690378, a Phase 2 study in complicated urinary tract infections; NCT01290900, a Phase 1 QT interval study in healthy male volunteers; NCT01291602, a Phase 1 study in healthy Japanese subjects; and NCT01448395, a Phase 1 mass balance study.

How does NXL104 work?

NXL104 is a small molecule being studied as a beta-lactamase inhibitor, designed to be combined with antibiotics like ceftazidime to overcome bacterial resistance. It is being evaluated for its ability to restore the effectiveness of these antibiotics against resistant bacteria.