Oral Civamide Safety, Tolerability First in Human Study

This study has been terminated.
(PK results demonstrated no systemic absorption)
Sponsor:
Information provided by:
Winston Laboratories
ClinicalTrials.gov Identifier:
NCT00802217
First received: November 26, 2008
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

Safety and pharmacokinetic first-time-in-human study of orally administered civamide in healthy subjects.


Condition Intervention Phase
Healthy
Drug: Civamide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1 Open-Label, Single-Dose, Dose Escalation Study in Healthy Subjects to Evaluate the Safety and Pharmacokinetics of Orally Administered Civamide (Zucapsaicin)

Further study details as provided by Winston Laboratories:

Primary Outcome Measures:
  • Measure the absorption of serum Civamide through pharmacokinetics assessments [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: November 2008
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cohort 1
Civamide liquid filled softgel capsule 5 mg
Drug: Civamide
5 mg liquid filled softgel capsules
Other Name: oral civamide
Active Comparator: Cohort 2
Civamide liquid filled soft gel capsules 2 x 5 mg
Drug: Civamide
5 mg x 2 liquid softgel capsules
Other Name: oral civamide

Detailed Description:

This is an open-label, non-randomized pharmacokinetic study of two dosage strengths of oral Civamide. The study consists of a Screening Period (Days -21 to Day -2), an Admittance Period, A 4 Day in-house Treatment Period(Days 1-4))and a follow-up Visit on Day 7.

Pharmacokinetics will be assessed at specified timepoints relative to dosing on Day 1 during the in-house stay. Subjects will be discharged from the research unit following the 72 hr blood draw.

Subjects will return to the research unit on Day 7 for a follow-up safety assessment.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
  2. Healthy, determined by pre-study medical evaluation (medical history and physical examination, vital signs, ECG, and clinical laboratory evaluations).
  3. Males or females between 18 to 45 years of age, inclusive.
  4. Female subjects must be of nonchildbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year) with follicle stimulating hormone [FSH] > 40 U/L).
  5. Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past year) and by urine cotinine concentration (< 200 ng/ml) at screening and/or Day -1.
  6. Body mass index (BMI) between 18.5 and 30.5 kg/m2, inclusive, at screening.
  7. Subject is willing and able to cooperate to the extent required by the protocol.

Exclusion Criteria:

  1. Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator or designee.
  2. Subjects with a history or clinical findings of coronary artery disease/cardiovascular disease or ECG findings judged clinically significant by the Investigator.
  3. Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
  4. Subjects with active upper gastrointestinal problems such as gastroesophageal reflux disease (GERD), or peptic ulcer disease.
  5. Subject has known allergy or hypersensitivity to capsicum, Civamide, or capsaicin-containing products.
  6. Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV antibody.
  7. Subject has history of alcohol and/or illicit drug abuse within two years of entry.
  8. Positive blood test for ethanol at screening or Day -1.
  9. Positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, tetrahydrocannabinol [THC], etc.) at screening or Day -1.
  10. Female subjects of childbearing potential or who are pregnant or breastfeeding.
  11. Inability to refrain from consumption of coffee and caffeine containing beverages within 24 hours prior to Day -1 until discharge from the unit on Day 4.
  12. Inability to refrain from use of alcohol or alcohol-containing foods, medications or beverages within 48 hours prior to Day -1 until discharge from the unit on Day 4.
  13. Topical use of any capsaicin-containing product for 60 days prior to Day -1 until end of study participation.
  14. Ingestion of any capsaicin-containing foods (capsicum, cayenne pepper, red pepper, green pepper, Scotch Bonnet, Habanero peppers, African chilies, Tabasco peppers, paprika, pimiento, Mexican chilies, Louisiana long pepper, Louisiana short pepper, Bird pepper, Garden pepper, Goat's pod, Grains of Paradise, Hot pepper, Hungarian Pepper, Ici Fructus, Sweet pepper, and Zanzibar pepper) for 48 hours before Day -1 until end of study participation.
  15. Donation of blood (> 250 ml) or blood products within 2 months (56 days) prior to Day -1.
  16. Consumption of grapefruit containing food/beverages or Seville oranges (orange marmalade) from 7 days prior to Day -1 until discharge from the unit on Day 4.
  17. Use of over the counter (OTC) medications (including vitamins), prescription medications, or herbal remedies from the 14 days prior to Day -1 until discharge from the unit on Day 4. By exception, acetaminophen £ 1 gram per day is permitted and hormone replacement therapy is permitted.
  18. Use of an investigational drug within 30 days prior to Day -1.
  19. Unwilling to abstain from vigorous exercise from 48 hours prior to Day -1 until discharge from the unit on Day 4.
  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: NCT00802217

Locations
United States, Maryland
Parexel International, Inc.
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Winston Laboratories
Investigators
Study Director: Scott B Phillips, M D Winston Laboratories
Principal Investigator: Shwe Gyaw, M D Parexel
  More Information

No publications provided

Responsible Party: Scott B. Phillips, M.D., Winston Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00802217     History of Changes
Other Study ID Numbers: WL-1001-03-01
Study First Received: November 26, 2008
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Winston Laboratories:
Pharmacokinetics
Safety
Tolerability
Healthy Volunteers

ClinicalTrials.gov processed this record on July 22, 2014