Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

Study Overview
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Brief Summary
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This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.

Official Title
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A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Velusetrag
* Drug: Velusetrag
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Is in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (PE), vital signs (VS) (including blood pressure and pulse rate measurement), 12-lead ECG, and clinical laboratory tests. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non-insulin dependent diabetes, osteoarthritis) may be enrolled if well controlled and not anticipated to interfere with the objectives of the study. Mild deviations from normal limits in PE, VS, ECG parameters, lab tests are acceptable if associated with the stable condition or are age-related Exclusion Criteria: Has a condition, which in the opinion of the investigator, would confound or interfere with evaluation of safety and tolerability or PK or PD of the investigational drug, or prevent compliance with the protocol

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose regimen 1<br>Varied doses | Drug: Velusetrag<br>* Capsules<br>|
| Experimental: Dose regimen 2<br>Varied doses | Drug: Velusetrag<br>* Capsules<br>|
| Experimental: Placebo<br>Matching placebo | Drug: Placebo<br>* Capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of repeat dosing of velusetrag | Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Plasma Pharmacokinetics (PK) of velusetrag and metabolite | Cmax (maximum observed concentration), Tmax (time of maximum observed concentration), AUC (area under the concentration-time curve) | Days 1, 7, 8, 14, 15, 21 at predose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours postdose and 24 hours postdose (and 48 and 72 h post Day 21 dose) | 
| Profile of urine PK of velusetrag and metabolite | Ae (amount excreted in urine), fe (fraction excreted in urine), CLr (renal clearance) | Days 1, 7, 8, 14, 15, 21 0-24h postdose and 24-72 h post Day 21 dose | 
| Pharmacodynamic effects of velusetrag | weekly bowel movement frequency | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, Elderly