A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-6463 when Administered to Healthy Volunteers as Single Ascending Doses with a Food Interaction Cohort, and as Multiple Ascending Doses
- Conditions
- Dementia10057167Alzheimer's disease
- Registration Number
- NL-OMON47937
- Lead Sponsor
- Cyclerion Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 138
1. Signed an ICF before any study-specific procedures are performed.
2. Age is *18 and <65 years at the Screening Visit.
3. Body mass index is *18.5 and <32 kg/m2 at the Screening Visit.
4. Ambulatory, in good health and no clinically significant findings on a
physical examination,
12-lead ECG, alcohol breathalyzer, and clinical laboratory tests (ie, serum
chemistry,
hematology, coagulation, urine drug screen, and urinalysis) after signing the
ICF but before
receiving the dose of study drug.
5. Screening results are negative for the hepatitis panel (hepatitis B surface
antigen [HBsAg],
the antihepatitis C virus [HCV]), and the human immunodeficiency virus (HIV)
antibody.
1. Participated in any clinical study or treated with any investigational drug
or device within 28 days prior to Screening.
2. Clinically significant manifestation of metabolic; hepatic; renal;
hematological; pulmonary; cardiovascular; gastrointestinal; endocrinological;
musculoskeletal; dermatological; urogenital; eye, ear, nose, and/or throat;
psychiatric (including history of clinical depression or suicidal ideation, any
cognitive impairment or dementia); or neurological disorder that, in
the opinion of the Investigator, precludes the subject from participating in
the study.
3. Lymphoma, leukemia, or any malignancy within the past 5 years. Exception:
Basal cell or squamous epithelial carcinomas of the skin that have been
resected with no evidence of
metastatic disease for 3 years.
4. Clinically significant hypersensitivity or allergy to any of the inactive
ingredients contained in the active or placebo drug products.
5. Active alcoholism or drug addiction during the 12 months before the
Screening Visit or has a positive urine drug screen or alcohol test (see
Section 8.1.7.2) at the Screening Visit or at
Check-in to the Study Center.
6. 12-lead ECG at the Screening Visit demonstrating severe bradycardia (HR <40
beats per minute) or average QT interval corrected for HR using Fridericia*s
formula (QTcF) *450 msec for men or *470 msec for women.
7. Family history of short QT syndrome or long QT syndrome.
8. Elevated levels (ie, >1.5× the upper limit of normal as defined by the
laboratory) at the Screening Visit or at Check-in of alanine aminotransferase,
aspartate aminotransferase, or
creatinine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Stage 1<br /><br>* Number of subjects with treatmentemergent adverse events (TEAEs) in the<br /><br>IW-6463 dose-level cohorts vs the (pooled) placebo group.<br /><br><br /><br>Stage 2<br /><br>* Number of subjects with TEAEs in the IW-6463 dose-level cohorts vs the<br /><br>(pooled) placebo group.<br /><br><br /><br>Stage 3<br /><br>* Number of subjects with TEAEs in the fed vs fasted dosing period.<br /><br>* Plasma concentration of IW-6463 after single-dose administration under fed vs<br /><br>fasted conditions.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable </p><br>