Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, Elderly
Brief summary
This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.
Interventions
DRUGVelusetrag
Capsules
DRUGPlacebo
Capsules
Sponsors
Theravance Biopharma
Alfasigma S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of repeat dosing of velusetrag | 3 weeks | Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Plasma Pharmacokinetics (PK) of velusetrag and metabolite | 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) | Cmax (maximum observed concentration), Tmax (time of maximum observed concentration), AUC (area under the concentration-time curve) |
| Profile of urine PK of velusetrag and metabolite | Days 1, 7, 8, 14, 15, 21 0-24h postdose and 24-72 h post Day 21 dose | Ae (amount excreted in urine), fe (fraction excreted in urine), CLr (renal clearance) |
| Pharmacodynamic effects of velusetrag | 3 weeks | weekly bowel movement frequency |
Countries
United States
Outcome results
None listed