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Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Velusetrag

Placebo

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, Elderly

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Comprehensive Clinical Development

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Dose regimen 1

Dose regimen 2

Placebo

Arm Description

Varied doses

Matching placebo

Outcomes

Primary Outcome Measures

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Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs

Secondary Outcome Measures

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)

Profile of urine PK of velusetrag and metabolite

Ae (amount excreted in urine), fe (fraction excreted in urine), CLr (renal clearance)

Pharmacodynamic effects of velusetrag

weekly bowel movement frequency

Full Information

NCT ID

NCT01467726

First Posted

October 28, 2011

Last Updated

December 1, 2014

Sponsor

Theravance Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT01467726

Brief Title

Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theravance Biopharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Alzheimer's disease, Elderly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose regimen 1

Arm Type

Experimental

Arm Description

Varied doses

Arm Title

Dose regimen 2

Arm Type

Experimental

Arm Description

Varied doses

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Matching placebo

Intervention Type

Drug

Intervention Name(s)

Velusetrag

Intervention Description

Capsules

Intervention Type

Drug

Intervention Name(s)

Velusetrag

Intervention Description

Capsules

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsules

Primary Outcome Measure Information:

Title

Tolerability of repeat dosing of velusetrag

Description

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

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Profile of Plasma Pharmacokinetics (PK) of velusetrag and metabolite

Description

Cmax (maximum observed concentration), Tmax (time of maximum observed concentration), AUC (area under the concentration-time curve)

Time Frame

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)

Title

Profile of urine PK of velusetrag and metabolite

Description

Ae (amount excreted in urine), fe (fraction excreted in urine), CLr (renal clearance)

Time Frame

Days 1, 7, 8, 14, 15, 21 0-24h postdose and 24-72 h post Day 21 dose

Title

Pharmacodynamic effects of velusetrag

Description

weekly bowel movement frequency

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Comprehensive Clinical Development

City

Miramar

State/Province

Florida

ZIP/Postal Code

33025

Country

United States

12. IPD Sharing Statement

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Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

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