A Single Dose Study to Determine the Safety and Pharmacokinetics of FP01 Lozenges in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cerecor Inc
ClinicalTrials.gov Identifier:
NCT01579526
First received: April 6, 2012
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to determine the safety and pharmacokinetics of FP01 in healthy volunteers.


Condition Intervention Phase
Healthy
Drug: FP01
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Randomized, Single Dose Study to Determine the Safety and Pharmacokinetics of FP01 Lozenges in Healthy Volunteers

Further study details as provided by Cerecor Inc:

Primary Outcome Measures:
  • Plasma pharmacokinetic profiles of the active pharmaceutical ingredient [ Time Frame: various timepoints over 72 hours ] [ Designated as safety issue: No ]
    Plasma PK profiles: various PK indices including, but not limited to, peak plasma concentration (Cmax), Area under the plasma concentration versus time curve (AUC), and elimination half-life (T1/2), and time to peak plasma concentration (Tmax).

  • Safety and Tolerability [ Time Frame: Various Timepoints over 72 Hours ] [ Designated as safety issue: Yes ]
    Safety and Tolerability will take into account the recorded AEs, vital signs, and clinical and laboratory assessments.


Enrollment: 40
Study Start Date: April 2012
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FP01 Dose 1
Drug
Drug: FP01
comparison of different dosages
Experimental: FP01 Dose 2
Drug
Drug: FP01
comparison of different dosages
Experimental: FP01 Dose 3
Drug
Drug: FP01
comparison of different dosages
Active Comparator: Comparator
Drug
Drug: FP01
comparison of different dosages

  Eligibility

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

INCLUSION CRITERIA

  1. Subjects are male and female volunteers 18 to 55 years of age inclusive.
  2. BMI between 18 and 30, inclusive.
  3. Subjects must have an estimated creatinine clearance rate of ≥ 80 mL/min as determined by the Cockcroft-Gault equation (see section 7.1).
  4. Female subjects of childbearing potential must be using adequate birth control as determined by the Investigator.
  5. Female subjects of childbearing potential must have negative pregnancy test results at screening and Day -1.
  6. Subjects must be able to provide informed consent after risks and benefits have been explained.
  7. Subjects must be non-smoking and non-tobacco user (defined as a subject who has not smoked or used tobacco products for ≥ 12 months from study screening), and must agree to abstain from alcohol and caffeine for 72 hours prior to study dosing and during their participation in the study.
  8. Subjects must have a 12 lead ECG without any clinically significant abnormalities of rate, rhythm, intervals or conduction, as determined by the Investigator.
  9. Subjects are in generally good health, based on pre-study medical history, physical examination and routine laboratory tests, as determined by the Investigator.
  10. Subjects who have no clinically significant disease and/or clinically significant abnormal laboratory values as determined by the Investigator based on medical history, physical examination, or laboratory evaluations conducted at the screening visit or on admission to the clinic.
  11. Be willing and able to comply with the study protocol requirements for the duration of the study, including pharmacokinetic sampling

EXCLUSION CRITERIA

  1. Females who are pregnant or lactating.
  2. Subjects who have a history of drug or alcohol abuse within 12 months of study screening, as determined by the Investigator.
  3. Subjects who have participated in any investigational trial within 30 days or six half-lives of the test drug's biologic activity, whichever is longer, before the start of the study (time of first dose).
  4. Subjects who have clinically significant medical or psychiatric illnesses currently or within 30 days of start of study (time of first dose), as determined by the Investigator.
  5. Subjects with any oral lesions observed at screening visit or at the Day -1 visit.
  6. Subjects who have a history of significant allergies (including history of asthma, food, or drug allergies), as determined by the Investigator.
  7. Subjects who have had significant blood loss, or have donated or received one or more pints of blood within 30 days prior to dosing.
  8. Subjects who have had symptoms of any significant acute illness including upper respiratory infections within 30 days prior to the start of study (time of first dose), as determined by the Investigator.
  9. Subjects who have any condition that interferes with their ability to understand or comply with the requirements of the study.
  10. Subjects who have a positive drug screen or alcohol screen at study screening or Day -1.
  11. Subjects who have any disease or condition (medical or surgical) that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or central nervous system function; or any other conditions that might interfere with the absorption, distribution, metabolism, or excretion of the study drug, or that would place the subject at increased risk, as determined by the Investigator.
  12. Subjects who have a positive result at screening for HIV, Hepatitis B, or Hepatitis C.
  13. Subjects who have received any concomitant prescription, over-the-counter, or herbal medications 7 days prior to study dosing, with the exception of hormonal contraceptives and up to 3 doses of acetaminophen at a dose of 1 gram or less from the time of study screening to the time of study dosing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579526

Locations
United States, Minnesota
Prism Research
Saint Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Cerecor Inc
  More Information

No publications provided

Responsible Party: Cerecor Inc
ClinicalTrials.gov Identifier: NCT01579526     History of Changes
Other Study ID Numbers: Clin01-001
Study First Received: April 6, 2012
Last Updated: May 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cerecor Inc:
Safety and Pharmacokinetics of FP01 in Healthy Volunteers

ClinicalTrials.gov processed this record on April 15, 2014