PharmacokineticsPhase 1NCT02215941
Study to Characterize the Pharmacokinetics and Safety of TV-45070 Ointment in Healthy Volunteers
A Phase 1 study testing TV-45070 in people with Pharmacokinetics, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial summary
The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in plasma following single and multiple-dose topical application of 8% TV-45070 ointment. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- TV-45070
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Feb 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects aged 18 to 50 years
- Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2.
- Able and willing to provide written informed consent.
- Able and willing to comply with all study procedures and restrictions.
Who cannot join
- History or evidence of clinically significant illness or surgery
- Presence of open wounds, sunburn, tattoo, major scarring, non-intact or damaged in the proposed application area that would interfere with the application of the study drug treatments or biopsies.
- History of significant drug or alcohol abuse
- Use of prescription drugs within 30 days or 5 half-lives (whichever is longer) prior to Day 1.
- Use of topical application of an OTC medicated or prescription medication or other skin creams/ointments (eg, moisturizers, balms) in the areas intended for study drug administration within 7 days prior to Day 1. Use of topical capsaicin within 6 months prior to Day 1.
- Pregnant or nursing females
Show all 9Show fewer
- Shaving or waxing the planned study treatment application area within 7 days prior Day 1.
- Laser hair removal of the planned study treatment application area within 2 months prior to Day 1.
- other criteria apply, please contact the investigator for more information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study to Characterize the Pharmacokinetics and Safety of 8% TV-45070 Ointment Following 7.5 Days of Twice Daily Topical Application in Healthy Subjects
The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in plasma following single and multiple-dose topical application of 8% TV-45070 ointment.
- Conditions
- Pharmacokinetics
- Being tested
- TV-45070, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV-45070Drug
TV-45070 8% ointment
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TV-45070 7% | Experimental | twice daily topical application to 7% body surface area for 7.5 days (15 applications) Receives: Drug: TV-45070 |
| TV-45070 21% | Experimental | twice daily topical application to 21% body surface area for 7.5 days (15 applications) Receives: Drug: TV-45070 |
| TV-45070 53% | Experimental | twice daily topical application to 53% body surface area for 7.5 days (15 applications) Receives: Drug: TV-45070 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations
Measured: Day 8
Secondary outcomes (7)
Drug level in skin
Measured: Days 1, 8, 15, 22, 29
Excretion of drug in urine
Measured: Day 8
Identification of metabolites in blood
Measured: Days 8, 10
Identification of metabolites in urine
Measured: Day 8
Identification of metabolites in skin
Measured: Days 1, 8, 15, 22, 29
Intraepidermal nerve fiber density in skin
Measured: Days 1, 8, 15, 29
Percentage of Participants with Adverse Events
Measured: 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215941
- Sponsor's protocol ID
- TV45070-PK-10033
- Status last verified
- Nov 2021
- First submitted
- 6 Aug 2014
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study to Characterize the Pharmacokinetics and Safety of 8% TV-45070 Ointment Following 7.5 Days of Twice Daily Topical Application in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02215941
- Acronym / sponsor ID
- TV45070-PK-10033
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Aug 2014 (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.
The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in plasma following single and multiple-dose topical application of 8% TV-45070 ointment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TV-45070 7% | Experimental | Drug: TV-45070twice daily topical application to 7% body surface area for 7.5 days (15 applications) |
| TV-45070 21% | Experimental | Drug: TV-45070twice daily topical application to 21% body surface area for 7.5 days (15 applications) |
| TV-45070 53% | Experimental | Drug: TV-45070twice daily topical application to 53% body surface area for 7.5 days (15 applications) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and/or female subjects aged 18 to 50 years
- Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2.
- Able and willing to provide written informed consent.
- Able and willing to comply with all study procedures and restrictions.
Key exclusion criteria (9 listed)
- History or evidence of clinically significant illness or surgery
- Presence of open wounds, sunburn, tattoo, major scarring, non-intact or damaged in the proposed application area that would interfere with the application of the study drug treatments or biopsies.
- History of significant drug or alcohol abuse
- Use of prescription drugs within 30 days or 5 half-lives (whichever is longer) prior to Day 1.
- Use of topical application of an OTC medicated or prescription medication or other skin creams/ointments (eg, moisturizers, balms) in the areas intended for study drug administration within 7 days prior to Day 1. Use of topical capsaicin within 6 months prior to Day 1.
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 |
|---|---|---|
| TV-45070TV-45070 8% ointment | Drug | TV-45070 21%, TV-45070 53%, TV-45070 7% |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Plasma concentrations
Time frame: Day 8
7 secondary outcomes
Drug level in skin
Time frame: Days 1, 8, 15, 22, 29
Excretion of drug in urine
Time frame: Day 8
Identification of metabolites in blood
Time frame: Days 8, 10
Identification of metabolites in urine
Time frame: Day 8
Identification of metabolites in skin
Time frame: Days 1, 8, 15, 22, 29
Intraepidermal nerve fiber density in skin
Time frame: Days 1, 8, 15, 29
Percentage of Participants with Adverse Events
Time frame: 10 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
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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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
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 TV-45070 in people with Pharmacokinetics, run by Teva Branded Pharmaceutical Products R&D, Inc. 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 9 Nov 2021. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma concentrations (time frame: Day 8). 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 9 Nov 2021.