Safety and Tolerability of STP206 in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sigma Tau Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00922324
First received: June 15, 2009
Last updated: May 16, 2013
Last verified: May 2011
  Purpose

The study will assess the safety, tolerability and fecal shedding of STP206 when given as a single dose and when given as daily doses for one week.


Condition Intervention Phase
Healthy
Drug: STP206 or vehicle control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Single-Center Randomized, Double-Blind, Placebo-Controlled Phase 1 Trial to Assess the Safety and Tolerability of Single and Multiple Daily Oral Administration of STP206 Live Biotherapeutic in Healthy Adult Subjects

Further study details as provided by Sigma Tau Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 7-days post dosing and 30-days post dosing ] [ Designated as safety issue: No ]
  • Changes in physical examination findings [ Time Frame: 7-days post dosing ] [ Designated as safety issue: No ]
  • Changes in laboratory (hematology, chemistry, and urinalysis) variables [ Time Frame: 7-days post dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fecal Shedding of STP206 components [ Time Frame: 30 days post dosing ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STP206
STP206 administered either as a single dose or as a daily dose for seven consecutive days
Drug: STP206 or vehicle control
STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days
Placebo Comparator: Vehicle Control
STP206 vehicle administered as either a single dose or as a daily dose for 7 consecutive days
Drug: STP206 or vehicle control
STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy volunteers, 18 - 55 years of age
  2. In general good heath as established by medical history, physical examination, and laboratory assessment
  3. The subject is willing and able to comply with the protocol and complete all visits and procedures
  4. Provide written informed consent after the nature of the study has been explained

Exclusion Criteria:

  1. Subjects with any chronic illness or conditions that require treatment
  2. Subjects with clinically significant abnormal laboratory values noted during the screening laboratory evaluation
  3. Subjects with history of immune compromised conditions or any past use of immunosuppressant treatment
  4. Subjects with current or past history of gastrointestinal disease, including any conditions with increased risk for bleeding (e.g., gingivitis, hemorrhoids)
  5. Subjects who are lactose intolerant
  6. Subjects who are intolerant or allergic to Splenda® or any of its ingredients (dextrose, maltodextrin, sucralose) or have a soy allergy
  7. Subjects who have had a fever of 100°F or higher within the 2 weeks of the first dose of study drug
  8. Subjects who have received a "live" vaccine within 30 days of the first dose of study drug
  9. Subjects who have received any medications (prescription or OTC) within 2 weeks of the first dose of study drug
  10. Subjects who have received and investigational drug with 30 days prior to the first dose of study drug
  11. Subjects with a history of illicit drug use or alcohol abuse
  12. Subjects with any other medical condition that may influence the objectives or outcomes of the study
  13. Female subjects who are pregnant or lactating
  14. Female subjects of childbearing potential who are not using an FDA approved birth control method
  15. Subjects who are healthcare or daycare providers or those with close contact with immune compromised individuals
  16. Subjects with a history of acute hepatitis, HIV infection or known to have positive diagnostic tests for HIV or HBV
  17. Subjects who have a planned dental appointment from screening through 7 days after last dose of Investigational Product.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922324

Locations
United States, Maryland
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Sigma Tau Pharmaceuticals, Inc.
Investigators
Study Director: Taha Keilani, MD Sigma Tau Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Sigma Tau Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00922324     History of Changes
Other Study ID Numbers: STP206-001
Study First Received: June 15, 2009
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sigma Tau Pharmaceuticals, Inc.:
Healthy volunteers

ClinicalTrials.gov processed this record on April 17, 2014