PainPhase 1NCT03770234
Clinical Study in Healthy Men to Investigate the Uptake of Buprenorphine and Its Elimination From the Body After Dermal Application as Patches for 96 Hours and for 72 Hours
A Phase 1 study testing Transtec 35 µg/hour transdermal patch in people with Pain and Pharmacokinetics, run by Grünenthal GmbH at 1 site in Germany.
Trial summary
The purpose of the study was to investigate the pharmacokinetics (i.e. the uptake, distribution and elimination from the body) of dermally applied buprenorphine during and after different application periods, i.e., a 96-hour and a 72-hour application of the Transtec (Registered Trademark) patch (release rate 35… Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Pharmacokinetics
- What is being tested?
- Transtec 35 µg/hour transdermal patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 5 Apr 2004to 26 May 2004
- 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 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male Caucasian volunteers, aged 25-45 years.
- Body mass index (BMI) between 18 and 30 kilogram/squared meter (extremes included).
- Good physical and mental health status (no current acute illness) determined on the basis of the medical history and a general clinical examination.
- Systolic blood pressure between 90 millimeter mercury (mmHg) and 150 mmHg (extremes included).
- Diastolic blood pressure between 45 mmHg and 90 mmHg (extremes included).
- Pulse rate between 45 beats per minute (bpm) and 100 bpm (extremes included).
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- Electrocardiogram (12 lead) considered as normal by the investigator.
- Results of laboratory tests within the normal ranges for the testing laboratory. The investigator may include a participant having values outside the accepted range if, in his/her opinion, these values are of no clinical relevance. The decision will be justified.
- The participant has been informed using the informed consent approved by the local ethics committee.
- The consent was obtained by participant's signature.
Who cannot join
- Diseases and functional disorders of the central nervous system (CNS), endocrinological system, gastrointestinal tract, hepatobiliary system, renal system, respiratory system or cardiovascular system including marked repolarization abnormality (e.g. suspicious or definite congenital long QT syndrome) or co-medication that is known to influence cardiac repolarization substantially.
- History of seizures or at risk (i.e. head trauma, epilepsy in family anamnesis, unclear loss of consciousness).
- Malignancy.
- History of orthostatic hypotension.
- Positive human immunodeficiency virus (HIV) 1/2-antibodies, hepatitis B surface (HBs) -antigen, hepatitis B core (HBc) -antibodies, hepatitis C virus (HCV) -antibody tests at the screening examination.
- Drug allergy.
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- Bronchial asthma.
- Participation in another clinical study within three month prior to the start of this study (exception: characterization of metabolizer status).
- Blood donation (more than 100 milliliters) within three month prior to the start of this study.
- Use of any medication within four weeks prior to the start of the study (self-medication or prescription).
- Evidence of alcohol, medication or drug abuse.
- Positive Naloxone challenge test.
- Positive drug abuse screening test.
- Extremely unbalanced diet (in the opinion of the investigator).
- Excessive consumption of food or beverages containing caffeine or other xanthines (more than five cups of coffee or equivalent per day).
- Smoking of more than 20 cigarettes per day.
- Neurotic personality, psychiatric illness or suicide risk.
- Known or suspected of not being able to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Pharmacokinetics of a Transtec® 35 µg/h Transdermal Patch Application for 96 Hours and a Patch Application for 72 Hours in an Open, Randomised, Single Application, Two-period Crossover, Phase I Study in 30 Healthy Male Volunteers
The purpose of the study was to investigate the pharmacokinetics (i.e. the uptake, distribution and elimination from the body) of dermally applied buprenorphine during and after different application periods, i.e., a 96-hour and a 72-hour application of the Transtec (Registered Trademark) patch (release rate 35 micrograms per hour [µg/hour]). In the Transtec summary of product characteristics (prescribing information for the physician), the wearing time per patch is restricted to three days (72 hours) after which the patch has to be replaced. However, market experience has shown that the Transtec patches are sometimes worn for a period longer than three days, i.e. they sometimes happen to be only replaced every four days. There was currently no data available as how to evaluate this longer wearing period.
- Conditions
- Pain, Pharmacokinetics
- Being tested
- Transtec 35 µg/hour transdermal patch
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtec 35 µg/hour transdermal patchDrug
Transdermal patch containing 20 mg buprenorphine in an active surface area of 25 squared centimeters. Buprenorphine release rate 35 µg/hour.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Transtec patch application for 96 hours | Experimental | Transtec 35 µg/hour transdermal patch wearing period of 96 hours, with application of patch on Study Day 1 and removal on Study Day 5. Receives: Drug: Transtec 35 µg/hour transdermal patch |
| Treatment B: Transtec patch application for 72 hours | Experimental | Transtec 35 µg/hour transdermal patch wearing period of 72 hours, with application of patch on Study Day 1 and removal on Study Day 4. Receives: Drug: Transtec 35 µg/hour transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter: AUC48-72 for buprenorphine
Partial area under the plasma concentration-time curve (from 48 hours after application until 72 hours after application).
Measured: From 48 hours to 72 hours
Pharmacokinetic parameter: AUC72-96 for buprenorphine
Partial area under the plasma concentration-time curve (from 72 hours after application until 96 hours after application).
Measured: From 72 hours to 96 hours
Secondary outcomes (8)
Pharmacokinetic parameter: Cmax for buprenorphine
Maximum observed plasma concentration of the measured concentration-time profile. Blood samples will be taken for the determination of buprenorphine plasma concentrations at distinct time points: Before application to 144 hours after patch application. If the patch was applied for 96 hours, additional samples were taken at 156 and 168 hours after application. For the analysis of buprenorphine in human plasma, a validated liquid chromatography mass spectrometry (LC/MS/MS)-method will be used.
Measured: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: tmax for buprenorphine
Time of maximum concentration, time after transdermal patch application at which Cmax occurs.
Measured: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: AUC0-t for buprenorphine
Area under plasma concentration-time curve from application until the last sampling point (t) with a quantifiable concentration, calculated by the linear/log trapezoidal method, i.e., the linear trapezoidal rule is applied up to Cmax and then the log trapezoidal rule is applied for the remainder of the curve.
Measured: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: t1/2z for buprenorphine
Apparent terminal elimination half-life.
Measured: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: AUC0-inf for buprenorphine
Area under the plasma concentration-time curve extrapolated to infinity.
Measured: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Incidence of treatment emergent adverse events
Number of adverse events and number of participants with adverse events.
Measured: From patch application (Day 1) until Final check (Day 12)
Characteristics of treatment emergent adverse events
Adverse events with information on intensity, seriousness, relationship to the investigational product, outcome and action taken will be determined.
Measured: From patch application (Day 1) until Final check (Day 12)
Onset and duration of treatment emergent adverse events
Adverse events with information on onset and duration to the investigational product will be determined.
Measured: From patch application (Day 1) until Final check (Day 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start5 Apr 2004
- Primary completion26 May 2004
- Study completion26 May 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will apply Transtec 35 µg/hour transdermal patch, once for 96 hours (Treatment A) and once for 72 hours (Treatment B) in randomized order. Between removal of the first patch and application of the second patch, there will be a washout period of at least 10 days.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grünenthal Study Director, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770234
- Sponsor's protocol ID
- HP5303/04
- Status last verified
- Dec 2018
- First submitted
- 7 Dec 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Pharmacokinetics of a Transtec® 35 µg/h Transdermal Patch Application for 96 Hours and a Patch Application for 72 Hours in an Open, Randomised, Single Application, Two-period Crossover, Phase I Study in 30 Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03770234
- Acronym / sponsor ID
- HP5303/04
- Conditions
- Pain, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2004 (actual)
- Primary completion
- 26 May 2004 (actual)
- Study completion
- 26 May 2004 (actual)
- First posted
- 10 Dec 2018 (actual)
- 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 purpose of the study was to investigate the pharmacokinetics (i.e. the uptake, distribution and elimination from the body) of dermally applied buprenorphine during and after different application periods, i.e., a 96-hour and a 72-hour application of the Transtec (Registered Trademark) patch (release rate 35 micrograms per hour [µg/hour]). In the Transtec summary of product characteristics (prescribing information for the physician), the wearing time per patch is restricted to three days (72 hours) after which the patch has to be replaced. However, market experience has shown that the Transtec patches are sometimes worn for a period longer than three days, i.e. they sometimes happen to be only replaced every four days. There was currently no data available as how to evaluate this longer wearing period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each participant will apply Transtec 35 µg/hour transdermal patch, once for 96 hours (Treatment A) and once for 72 hours (Treatment B) in randomized order. Between removal of the first patch and application of the second patch, there will be a washout period of at least 10 days.
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Transtec patch application for 96 hours | Experimental | Drug: Transtec 35 µg/hour transdermal patchTranstec 35 µg/hour transdermal patch wearing period of 96 hours, with application of patch on Study Day 1 and removal on Study Day 5. |
| Treatment B: Transtec patch application for 72 hours | Experimental | Drug: Transtec 35 µg/hour transdermal patchTranstec 35 µg/hour transdermal patch wearing period of 72 hours, with application of patch on Study Day 1 and removal on Study Day 4. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male Caucasian volunteers, aged 25-45 years.
- Body mass index (BMI) between 18 and 30 kilogram/squared meter (extremes included).
- Good physical and mental health status (no current acute illness) determined on the basis of the medical history and a general clinical examination.
- Systolic blood pressure between 90 millimeter mercury (mmHg) and 150 mmHg (extremes included).
- Diastolic blood pressure between 45 mmHg and 90 mmHg (extremes included).
Key exclusion criteria (18 listed)
- Diseases and functional disorders of the central nervous system (CNS), endocrinological system, gastrointestinal tract, hepatobiliary system, renal system, respiratory system or cardiovascular system including marked repolarization abnormality (e.g. suspicious or definite congenital long QT syndrome) or co-medication that is known to influence cardiac repolarization substantially.
- History of seizures or at risk (i.e. head trauma, epilepsy in family anamnesis, unclear loss of consciousness).
- Malignancy.
- History of orthostatic hypotension.
- Positive human immunodeficiency virus (HIV) 1/2-antibodies, hepatitis B surface (HBs) -antigen, hepatitis B core (HBc) -antibodies, hepatitis C virus (HCV) -antibody tests at the screening examination.
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 |
|---|---|---|
| Transtec 35 µg/hour transdermal patchTransdermal patch containing 20 mg buprenorphine in an active surface area of 25 squared centimeters. Buprenorphine release rate 35 µg/hour. | Drug | Treatment A: Transtec patch application for 96 hours, Treatment B: Transtec patch application for 72 hours |
Primary outcome
Pharmacokinetic parameter: AUC48-72 for buprenorphine
Time frame: From 48 hours to 72 hours
Partial area under the plasma concentration-time curve (from 48 hours after application until 72 hours after application).
Pharmacokinetic parameter: AUC72-96 for buprenorphine
Time frame: From 72 hours to 96 hours
Partial area under the plasma concentration-time curve (from 72 hours after application until 96 hours after application).
8 secondary outcomes
Pharmacokinetic parameter: Cmax for buprenorphine
Time frame: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: tmax for buprenorphine
Time frame: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: AUC0-t for buprenorphine
Time frame: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: t1/2z for buprenorphine
Time frame: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Pharmacokinetic parameter: AUC0-inf for buprenorphine
Time frame: Before application and after 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104,112,120,132,144,156, and 168 hours
Incidence of treatment emergent adverse events
Time frame: From patch application (Day 1) until Final check (Day 12)
Characteristics of treatment emergent adverse events
Time frame: From patch application (Day 1) until Final check (Day 12)
Onset and duration of treatment emergent adverse events
Time frame: From patch application (Day 1) until Final check (Day 12)
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 10 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Grünenthal Study Director study director
Grünenthal GmbH
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 Transtec 35 µg/hour transdermal patch in people with Pain and Pharmacokinetics, run by Grünenthal GmbH at 1 site in Germany.
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 10 inclusion and 18 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 10 Dec 2018. 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 Germany. 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 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?
Pharmacokinetic parameter: AUC48-72 for buprenorphine (time frame: From 48 hours to 72 hours). The study lists 2 primary outcomes in all. 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 Dec 2018.