NCT04074837
Completed
Phase 1
Phase1a, Randomized Placebo-controlled, Single and Multiple Dose, Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNI-362 in Healthy Aged Volunteers 50 to 72 Years of Age
ConditionsAlzheimer Disease
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Alzheimer Disease
- Sponsor
- Neuronascent, Inc.
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Measure number of treatment related adverse events following single and multiple dosing of NNI-362.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to examine the safety, tolerability and pharmacokinetics of single and multiple doses of NNI-362 in healthy aged population.
Detailed Description
The early clinical development strategy consists of the initial evaluation of safety and tolerability of NNI-362. This FIH Phase I includes single and multiple ascending dose studies in healthy aged volunteers. Assessment of suicidal ideation/behavior will be performed at baseline and at all study visits and on days of inpatient confinement in conformance with FDA recommendations.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy aged volunteers of either sex between the ages of 50 and 72 inclusive at time of screening.
- •Subjects must be in reasonably good health as determined by investigator based on medical history, vital signs measurements, physical examination, screening laboratory results and ECG.
- •Normal age-related findings as well as well-controlled, chronic and stable medical conditions (e.g., hypertension, osteoarthritis, non-insulin dependent diabetes mellitus, osteoporosis, gout, Paget's disease, hypothyroidism) will not be exclusionary if they are not expected to compromise subject safety, study conduct, or study objectives.
- •Non-interacting medications for stable allowable medical conditions will be allowed following review and approval by the medical monitor.
- •An adequate understanding of the requirements of the study, provision of written informed consent, and agreement to abide by the study restrictions.
- •Negative urine screen for drugs of abuse within 24 h before the administration of the first dose of study drug and in the multiple dose study upon readmission to the clinical unit from outpatient status.
- •Body Mass Index (BMI) of between 18 and 30 kg/m2 inclusive, and a total body weight greater than 48kg at screening.
Exclusion Criteria
- •• Women of child-bearing potential, defined as premenopausal (unless the potential research subject has previously undergone hysterectomy and/or bilateral salpingo-oophorectomy)
- •Pregnant or breastfeeding
- •Any clinically significant hematology, chemistry, coagulation, or urinalysis value at screening and day -1 Abnormal liver enzymes (ALT and/or AST \>1.5X ULN) at screening and day -1
- •Serum creatinine \> ULN at screening and day -1
- •Hemoglobin \<13 g/dL for males or \<11.5 g/dL for females, leukocytes \<3.0 X 103/uL, absolute neutrophil count \<1000/uL, or platelets \<150 X 103/uL at screening and day -1
- •Any significant medical illness that could compromise the interpretability of study data or affect subject safety including, but not necessarily limited to:
- •Chronic pulmonary disease or sleep apnea
- •Clinically significant cardiac arrhythmia (either at screening or based on history)
- •Congestive heart failure, valvular heart disease or ischemic heart disease
- •Pulmonary hypertension
Arms & Interventions
Placebo
Placebo liquid suspension.
Intervention: Placebo
NNI-362, 10 mg
NNI-362 at 10 mg in liquid suspension
Intervention: NNI-362
NNI-362, 20 mg
NNI-362 at 20 mg in liquid suspension
Intervention: NNI-362
NNI-362, 60 mg
NNI-362 at 60 mg in liquid suspension
Intervention: NNI-362
NNI-362, 120 mg
NNI-362 at 120 mg in liquid suspension
Intervention: NNI-362
NNI-362, 240 mg
NNI-362 at 240 mg in liquid suspension
Intervention: NNI-362
Outcomes
Primary Outcomes
Measure number of treatment related adverse events following single and multiple dosing of NNI-362.
Time Frame: 5 to 15 days
To examine the number of participants with treatment-related adverse events according to criteria of CTCAE v4.0
Secondary Outcomes
- Measure Area Under the Curve with single and multiple dosing of NNI-362(48 hours)
- Measure Maximum Plasma Concentration with single or multiple dosing of NNI-362.(48 hours)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of SPR206 in Healthy VolunteersHealthy VolunteersNCT03792308Spero Therapeutics94
Terminated
Phase 1
The Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of BWC0977 in Healthy Adult VolunteersInfectious DiseasesBacterial InfectionsNCT05942820Bugworks Research Inc.4
Completed
Phase 1
A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of BWC0977 in Healthy VolunteersInfectious DiseasesBacterial InfectionsNCT05088421Bugworks Research Inc.44
Completed
Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian ParticipantsHealthy VolunteerNCT03188783Hoffmann-La Roche32
Completed
Phase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian SubjectsPharmacokinetics of FidaxomicinHealthy SubjectsNCT01813448Astellas Pharma Global Development, Inc.36