Status:
COMPLETED
MW151-101: First-in-human Study of MW151
Lead Sponsor:
Linda Van Eldik
Collaborating Sponsors:
Duke Clinical Research Institute
National Institute on Aging (NIA)
Conditions:
Drug Toxicity
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
MW01-2-151SRM (=MW151), a small molecule, is being developed for the treatment of cognitive disorders. The development program is based on nonclinical evidence that MW151 improves neurocognitive outco...
Detailed Description
The primary objective of this trial is to assess the safety and tolerability of single ascending doses of MW151 when administered orally to healthy adults. Subjects will be screened prior to inpatien...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent
- In good health as determined by medical history, physical exam, laboratory examinations, ECG, and vital signs.
- Weight \>50kg
- BMI \<34 kg/m2.
- ECG without clinically significant pathologic abnormalities and with QTcF \<450 ms -
- Systolic BP ≤ 150 mmHg and diastolic BP ≤ 90 mmHg at screening
- No suicidal ideation, as demonstrated by a score of "0" on the Columbia Suicide Severity Rating Scale (C-SSRS).
- Women who are neither pregnant (negative pregnancy test) nor nursing, and are either: surgically sterile, postmenopausal with last natural menses greater than 24 months, or premenopausal and agrees to use and acceptable form of birth control during the study and for 1 month after dosing.
- Adequate venous access for blood draws.
Exclusion
- Any unstable chronic medical condition requiring interventional treatment that might increase the risk to the subject or confound interpretation of safety observations. Subjects who are considered stable and who have been receiving stable treatment for medical condition for \> 3 months may be considered with approval of medical monitor.
- Evidence of active infection requiring antibiotic therapy within 14 days prior to dosing.
- Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis.
- History of any treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin.
- Seropositive for human immunodeficiency virus (HIV).
- History of acute/chronic hepatitis B or C and/or carriers of hepatitis B
- Clinically significant abnormalities in screening laboratory tests
- Over-the-counter and herbal medications are prohibited within 10 days prior to study dosing (with exception of calcium/vitamin D supplements and ocular medications at the discretion of the Investigator). Stable doses (\> to 3 months of stable dose) of prescription medications are allowed with the approval of the medical monitor (birth control medications are allowed without medical monitor approval). Subjects should not be on non-steroidal anti-inflammatory drugs or immunosuppressive drugs within 10 days prior to dosing.
- Use of known CYP450 CYP1A2, CYP2D6 or CYP3A4 inhibitors or inducers within 14 days of dosing or planned use during the study.
- Use of an investigational drug, vaccine, device, or blood product within 3 months prior to dosing in this study.
- Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs (e.g. small bowel disease, Crohn's disease, celiac disease, or liver disease.)
- Psychiatric history of current or past psychosis, bi-polar disorder, clinical depression, or anxiety disorder requiring chronic medication within the past 5 years.
- History of substance abuse including alcohol within the past 5 years.
- Smoker.
- Current substance or drug dependence confirmed by positive urine drug screen at screening visit or Day -1 admission.
- Current alcohol abuse confirmed by positive breathalyzer at screening visit or Day -1 admission.
- History of serious head injury as determined by the site investigator or designee.
- Chronic kidney disease (defined as the presence of any degree of proteinuria on urine analysis and/or an eGFR of \<60 ml/min using the MDRD formula).
- Any reason or opinion of the investigator that would prevent the subject from participation in the study.
- Inability to follow the instructions or an unwillingness to cooperate with study procedures.
- Has donated more than 500 mL of blood within the last month prior to dosing.
Key Trial Info
Start Date :
October 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04120233
Start Date
October 22 2019
End Date
September 16 2021
Last Update
December 30 2022
Active Locations (1)
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1
Duke Clinical Research Institute
Durham, North Carolina, United States, 27705