HealthyPhase 1NCT00802217
Oral Civamide Safety, Tolerability First in Human Study
A Phase 1 study testing Civamide in people with Healthy, run by Winston Laboratories at 1 site in United States.
Trial summary
Safety and pharmacokinetic first-time-in-human study of orally administered civamide in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Civamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
- Healthy, determined by pre-study medical evaluation (medical history and physical examination, vital signs, ECG, and clinical laboratory evaluations).
- Males or females between 18 to 45 years of age, inclusive.
- 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).
- 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.
- Body mass index (BMI) between 18.5 and 30.5 kg/m2, inclusive, at screening.
- Subject is willing and able to cooperate to the extent required by the protocol.
Who cannot join
- 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.
- Subjects with a history or clinical findings of coronary artery disease/cardiovascular disease or ECG findings judged clinically significant by the Investigator.
- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Subjects with active upper gastrointestinal problems such as gastroesophageal reflux disease (GERD), or peptic ulcer disease.
- Subject has known allergy or hypersensitivity to capsicum, Civamide, or capsaicin-containing products.
- Positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or HIV antibody.
Show all 19Show fewer
- Subject has history of alcohol and/or illicit drug abuse within two years of entry.
- Positive blood test for ethanol at screening or Day -1.
- Positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, tetrahydrocannabinol [THC], etc.) at screening or Day -1.
- Female subjects of childbearing potential or who are pregnant or breastfeeding.
- 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.
- 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.
- Topical use of any capsaicin-containing product for 60 days prior to Day -1 until end of study participation.
- 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.
- Donation of blood (> 250 ml) or blood products within 2 months (56 days) prior to Day -1.
- 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.
- 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.
- Use of an investigational drug within 30 days prior to Day -1.
- Unwilling to abstain from vigorous exercise from 48 hours prior to Day -1 until discharge from the unit on Day 4.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel International, Inc.
Baltimore, Maryland, 21225
About this study
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)
Safety and pharmacokinetic first-time-in-human study of orally administered civamide in healthy subjects.
Read the 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.
- Conditions
- Healthy
- Being tested
- Civamide
- Keywords
- Pharmacokinetics, Safety, Tolerability, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CivamideDrug
Also called oral civamide
5 mg liquid filled softgel capsules
CivamideDrug
Also called oral civamide
5 mg x 2 liquid softgel capsules
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Civamide liquid filled softgel capsule 5 mg Receives: Drug: Civamide |
| Cohort 2 | Active comparator | Civamide liquid filled soft gel capsules 2 x 5 mg Receives: Drug: Civamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the absorption of serum Civamide through pharmacokinetics assessments
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionJul 2009
Why it stopped: PK results demonstrated no systemic absorption
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Winston Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott B Phillips, M D, Study director, Winston LaboratoriesShwe Gyaw, M D, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802217
- Sponsor's protocol ID
- WL-1001-03-01
- Status last verified
- Jun 2011
- First submitted
- 26 Nov 2008
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00802217
- Acronym / sponsor ID
- WL-1001-03-01
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Safety, Tolerability, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PK results demonstrated no systemic absorption
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Winston LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and pharmacokinetic first-time-in-human study of orally administered civamide in healthy subjects.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: CivamideCivamide liquid filled softgel capsule 5 mg |
| Cohort 2 | Active comparator | Drug: CivamideCivamide liquid filled soft gel capsules 2 x 5 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
- Healthy, determined by pre-study medical evaluation (medical history and physical examination, vital signs, ECG, and clinical laboratory evaluations).
- Males or females between 18 to 45 years of age, inclusive.
- 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).
- 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.
Key exclusion criteria (19 listed)
- 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.
- Subjects with a history or clinical findings of coronary artery disease/cardiovascular disease or ECG findings judged clinically significant by the Investigator.
- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Subjects with active upper gastrointestinal problems such as gastroesophageal reflux disease (GERD), or peptic ulcer disease.
- Subject has known allergy or hypersensitivity to capsicum, Civamide, or capsaicin-containing products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CivamideAlso: oral civamide5 mg liquid filled softgel capsules | Drug | Cohort 1 |
| CivamideAlso: oral civamide5 mg x 2 liquid softgel capsules | Drug | Cohort 2 |
Primary outcome
Measure the absorption of serum Civamide through pharmacokinetics assessments
Time frame: 4 days
Results and safety
The study was stopped early (reason given: PK results demonstrated no systemic absorption). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott B Phillips, M D study director
Winston Laboratories
Shwe Gyaw, M D principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Civamide in people with Healthy, run by Winston Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PK results demonstrated no systemic absorption). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the absorption of serum Civamide through pharmacokinetics assessments (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.