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Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

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ClinicalTrials.gov Identifier: NCT01467726
Recruitment Status : Completed
First Posted : November 9, 2011
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Velusetrag Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Placebo−Controlled, Double−Blind, Study of Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects
Study Start Date : November 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dose regimen 1
Varied doses
Drug: Velusetrag
Capsules
Experimental: Dose regimen 2
Varied doses
Drug: Velusetrag
Capsules
Experimental: Placebo
Matching placebo
Drug: Placebo
Capsules


Outcome Measures

Primary Outcome Measures :
  1. Tolerability of repeat dosing of velusetrag [ Time Frame: 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    Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs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 :
  1. Profile of Plasma Pharmacokinetics (PK) of velusetrag and metabolite [ 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) ]
    Cmax (maximum observed concentration), Tmax (time of maximum observed concentration), AUC (area under the concentration-time curve)

  2. Profile of urine PK of velusetrag and metabolite [ Time Frame: 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)

  3. Pharmacodynamic effects of velusetrag [ Time Frame: 3 weeks ]
    weekly bowel movement frequency


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467726


Locations
United States, Florida
Comprehensive Clinical Development
Miramar, Florida, United States, 33025
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
More Information

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT01467726     History of Changes
Other Study ID Numbers: 0048
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Theravance Biopharma R & D, Inc.:
Alzheimer's disease
Elderly

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders