Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: Velusetrag

• Registration Number: NCT01467726
• Lead Sponsor: Theravance Biopharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-28
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-09
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo
Dose regimen 1	Velusetrag	Varied doses
Dose regimen 2	Velusetrag	Varied doses

Primary Outcome Measures

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Tolerability of repeat dosing of velusetrag	3 weeks	Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs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

Name	Time	Method
Pharmacodynamic effects of velusetrag	3 weeks	weekly bowel movement frequency
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)
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)

Trial Locations

Locations (1)

Comprehensive Clinical Development; 🇺🇸 Miramar, Florida, United States