Status:
COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects
Lead Sponsor:
Alfasigma S.p.A.
Collaborating Sponsors:
Theravance Biopharma
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
65-85 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01467726
Start Date
November 1 2011
End Date
January 1 2012
Last Update
July 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Comprehensive Clinical Development
Miramar, Florida, United States, 33025