Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics Study of NDX-1017
Lead Sponsor:
Athira Pharma
Collaborating Sponsors:
Alzheimer's Drug Discovery Foundation
Biotrial Inc.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of NDX-1017 in healthy...
Detailed Description
NDX-1017 is being developed for the treatment of Alzheimer's disease (AD). This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and ph...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Generally in good health
- Body mass index (BMI) of ≥ 18.0 and ≤ 30.0 kg/m2 at Screening, with minimum weight of 60 kg. (No BMI upper limit for mild AD and amnestic MCI subjects)
- Male subjects and their partners must be willing to comply with the contraceptive requirements of the study. Only female subjects of non-childbearing potential are eligible for participation.
- \[Young subjects\] Male subjects must be aged 18 to 45 years (inclusive) at the time of Screening.
- \[Healthy elder subjects only\] Male and female subjects must be aged 60 to 85 years at the time of screening
- \[Amnestic MCI and Alzheimer's Subjects\] 9. Patients with Alzheimer's disease, with confirmed diagnosis of amnestic mild cognitive impairment, Alzheimer's disease (mild, mild-to-moderate, or moderate), or mixed dementia with Alzheimer's and vascular components (mild, mild-to-moderate, or moderate).
- Either newly diagnosed treatment naïve patients, OR,
- Patients who are currently on standard Alzheimer's Disease treatment may be considered for participation if they are not tolerating treatment and/or they are willing and clinically able to tolerate a discontinuation, 14 days for dose titration + 5x half-lives for washout, or 4 weeks (whichever is longer) prior to randomization. For these patients, the screening window will be allowed for up to 90 days prior to randomization to evaluate discontinuation of symptomatic treatment for Alzheimer's disease.
- EXCLUSION CRITERIA:
- Any medical condition that requires chronic medication use.
- History of drug and/or alcohol abuse within 12 months prior to Screening.
- History of having taken another investigational drug within 30 days prior to Admission (Day -1).
- Donation of blood or plasma within 30 days prior to dosing.
- Major surgery within 90 days prior to Admission (Day -1) or anticipated surgery during the study.
- Smokers
- \[Healthy elderly subjects\] Reported changes in cognition and reported history of declines in everyday life in the last year.
Exclusion
Key Trial Info
Start Date :
October 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2019
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03298672
Start Date
October 9 2017
End Date
September 5 2019
Last Update
September 10 2019
Active Locations (1)
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1
Biotrial Inc.
Newark, New Jersey, United States, 07103