- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04074837
Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged Volunteers
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Parexel International
- Phone Number: 814-254-1600
- Email: study.losangeles@Parexel.com
Study Locations
-
-
California
-
Glendale, California, United States, 91206
- Parexel, International
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- Any disorder of the kidney or urinary tract
- Active peptic ulcer disease, gastrointestinal bleeding, inflammatory bowel disease, chronic pancreatitis
- Liver disease (excluding Gilbert's syndrome)
- Any neurologic disorder other than chronic Bell's Palsy
- History of malignancy that has not been cured or in complete remission for at least 10 years (excluding resected non-metastatic basal cell carcinoma)
- History of seizure activity other than early childhood
- Any traumatic brain injury in adulthood
- Current smoker or nicotine user (quit less than 2 months)
- Active substance abuse.
- Glomerular filtration rate <50 mL/min based on Cockcroft-Gault calculation using ideal (lean) body weight or present weight.
- Difficulty swallowing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo liquid suspension.
|
Placebo liquid suspension
|
Active Comparator: NNI-362, 10 mg
NNI-362 at 10 mg in liquid suspension
|
NNI-362 small molecule in liquid suspension.
|
Active Comparator: NNI-362, 20 mg
NNI-362 at 20 mg in liquid suspension
|
NNI-362 small molecule in liquid suspension.
|
Active Comparator: NNI-362, 60 mg
NNI-362 at 60 mg in liquid suspension
|
NNI-362 small molecule in liquid suspension.
|
Active Comparator: NNI-362, 120 mg
NNI-362 at 120 mg in liquid suspension
|
NNI-362 small molecule in liquid suspension.
|
Active Comparator: NNI-362, 240 mg
NNI-362 at 240 mg in liquid suspension
|
NNI-362 small molecule in liquid suspension.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 to 15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure Maximum Plasma Concentration with single or multiple dosing of NNI-362.
Time Frame: 48 hours
|
Following single and multiple dosing of oral NNI-362 assess the maximum plasma concentration [Cmax].
|
48 hours
|
Measure Area Under the Curve with single and multiple dosing of NNI-362
Time Frame: 48 hours
|
Following single and multiple dosing of oral NNI-362 assess the area under the curve [AUC].
|
48 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NNI-001
- 1R01AG056561-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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