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Safety, Pharmacokinetics and Pharmacodynamics of Velusetrag in Healthy Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier:
NCT01467726
First received: October 28, 2011
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: Velusetrag
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:
  • Tolerability of repeat dosing of velusetrag [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
    Number of subjects who complete the treatment period and are not withdrawn due to adverse events (AEs) or clinically significant findings on vital signs or ECGs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 [ 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) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Days 1, 7, 8, 14, 15, 21 0-24h postdose and 24-72 h post Day 21 dose ] [ Designated as safety issue: No ]
    Ae (amount excreted in urine), fe (fraction excreted in urine), CLr (renal clearance)

  • Pharmacodynamic effects of velusetrag [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    weekly bowel movement frequency


Enrollment: 40
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467726

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

No publications provided

Responsible Party: Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier: NCT01467726     History of Changes
Other Study ID Numbers: 0048
Study First Received: October 28, 2011
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
Alzheimer's disease
Elderly

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 25, 2014