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

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 - IW 6463 in healthy subjects as a SAD, MAD and Food interaction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47937

Enrollment

138

Registered

2019-01-04

Start date

2019-01-17

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease Dementia

Interventions

* Orally administered IW-6463 Tablets at doses ranging from 0.3 mg/day to not more than 50 mg/day * Orally administered Placebo to Match IW-6463 Tablets

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Signed an ICF before any study-specific procedures are performed. 2. Age is *18 and

Exclusion criteria

Exclusion criteria: 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 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.

Design outcomes

Primary

Measure	Time frame
Stage 1 * Number of subjects with treatmentemergent adverse events (TEAEs) in the IW-6463 dose-level cohorts vs the (pooled) placebo group. Stage 2 * Number of subjects with TEAEs in the IW-6463 dose-level cohorts vs the (pooled) placebo group. Stage 3 * Number of subjects with TEAEs in the fed vs fasted dosing period. * Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions.	—

Measure

Time frame

Stage 1 * Number of subjects with treatmentemergent adverse events (TEAEs) in the IW-6463 dose-level cohorts vs the (pooled) placebo group. Stage 2 * Number of subjects with TEAEs in the IW-6463 dose-level cohorts vs the (pooled) placebo group. Stage 3 * Number of subjects with TEAEs in the fed vs fasted dosing period. * Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)