Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467726
• Other study ID #: 0048
• Status: Completed
• Phase: Phase 1
• First received: October 28, 2011
• Last updated: December 1, 2014
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: December 2014
• Source: Theravance Biopharma R & D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Velusetrag
Capsules
• Velusetrag
Capsules
• Placebo
Capsules

Locations

Country	Name	City	State
United States	Comprehensive Clinical Development	Miramar	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma R & D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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)	No
Secondary	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	No
Secondary	Pharmacodynamic effects of velusetrag	weekly bowel movement frequency	3 weeks	No