Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects
1 other identifier
interventional
40
1 country
1
Brief Summary
This is a Phase 1, Randomized, Placebo-Controlled, Double-Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJuly 8, 2025
December 1, 2014
2 months
October 28, 2011
July 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs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 Outcomes (3)
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)
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
Pharmacodynamic effects of velusetrag
3 weeks
Study Arms (3)
Dose regimen 1
EXPERIMENTALVaried doses
Dose regimen 2
EXPERIMENTALVaried doses
Placebo
EXPERIMENTALMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alfasigma S.p.A.lead
- Theravance Biopharmacollaborator
Study Sites (1)
Comprehensive Clinical Development
Miramar, Florida, 33025, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2011
First Posted
November 9, 2011
Study Start
November 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
July 8, 2025
Record last verified: 2014-12