HealthyPhase 1NCT01259102

Examine Plasma Concentrations of Buprenorphine Following Reapplication of Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods

A Phase 1 study testing Buprenorphine transdermal patch in people with Healthy, run by Purdue Pharma LP at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals. 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?: Buprenorphine transdermal patch
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: Nov 2000to Mar 2001
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Males and females 18 to 45 years of age, inclusive.
Weight of 60 to 100 kilograms (kg) [132-220 pounds (lb)] and within 15% of optimum for height and body frame.
In good health, evidenced by a lack of significantly abnormal findings on medical history, physical examination, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
Willing to discontinue and abstain from any medications, including vitamins or mineral supplements, throughout the study.
Willing to follow dietary restrictions, including abstention from caffeine and xanthine-containing beverages for the duration of the study.
Did not smoke or chew tobacco for at least 45 days prior to administration of study drugs, and agree not to use tobacco products during the study

Who cannot join

A history of hypersensitivity to opioid or psychotropic drugs.
A history of recurrent seizures or syncope.
Any medical or surgical conditions which might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
Any other significant active medical illness such as: history or presence of liver disease or liver injury that is indicated by an abnormal liver function profile such as aspartate transaminase (AST), alanine transaminase (ALT), or serum bilirubin; history or presence of impaired renal function that is indicated by abnormal creatinine or blood urea nitrogen (BUN) values or abnormal urinary constituents (eg, albuminuria); history of neutropenia (absolute neutrophil count [ANC] <1000/mm3 or thrombocytopenia (platelet <150,000/mm3).
Positive results of urine drug screen or urine cotinine (consistent with active smoking).
A history of substance or alcohol abuse within the past 5 years.

Show all 9Show fewer

Females who are nursing.
Females who are pregnant as confirmed by a positive serum human chorionic gonadotropin (bHCG) test.
Other protocol-specific exclusion/inclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Department of Pharmacology
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Parallel Open-Label Study to Examine Plasma Concentrations of Buprenorphine Following Reapplication of 10-mg Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods in Healthy Subjects

The purpose of this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.

Read the detailed description

The purpose of this study is to determine the minimum application site rest period that ensures that reapplication of BTDS 10 to the same site in the deltoid region does not result in increased absorption of drug in normal healthy subjects.

Conditions: Healthy
Being tested: Buprenorphine transdermal patch
Keywords: Healthy subjects, Opioid, Transdermal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Buprenorphine transdermal patchDrug
Also called Butrans™
Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

Study groups in NCT01259102
Study group	Role	What they receive
No Rest	Experimental	BTDS 10 with no application site rest period prior to application of second BTDS Receives: Drug: Buprenorphine transdermal patch
7-Day Rest	Experimental	BTDS 10 with 7-day rest period prior to application of second BTDS Receives: Drug: Buprenorphine transdermal patch
14-Day Rest	Experimental	BTDS 10 with 14-day rest period prior to application of second BTDS Receives: Drug: Buprenorphine transdermal patch
21-Day Rest	Experimental	BTDS 10 with 21-day rest period prior to application of second BTDS Receives: Drug: Buprenorphine transdermal patch
28-Day Rest	Experimental	BTDS 10 with 28-day rest period prior to application of second BTDS Receives: Drug: Buprenorphine transdermal patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Period 1: AUC0-3d
Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d [The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)].
Measured: 0 to 3 days (72 hours)
Period 2: AUC0-3d.
Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d.
AUC0-3d - The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours).
Measured: 0 to 3 days
Period 1: Cmax0-3d
Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.
Cmax0-3d - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug.
Measured: 0 to 3 days
Period 2: Cmax0-3d
Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d.
Cmax0-3d (pg/mL) - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug.
Measured: 0 to 3 days

Secondary outcomes (6)

Period 1: AUC0-7d.
Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.
AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal.
Measured: 0 to 7 days
Period 2: AUC0-7d
Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by AUC0-7d.
AUC0-7d - The area under the plasma concentration-time course profile from time = 0 (dosing) to BTDS removal.
Measured: 0 to 7 days
Period 1: Cmax0-7
Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7.
Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile.
Measured: 0 to 7 days
Period 2: Cmax0-7d
Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Cmax0-7d.
Cmax0-7d - The maximum observed concentration taken directly from the plasma concentration-time course profile.
Measured: 0 to 7 days
Period 1: Tmax0-7d.
Period 1 was the first application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.
Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax.
Measured: 0 to 7days
Period 2: Tmax0-7d.
Period 2 was the second application of BTDS 10: The time for absorption to return to normal measured by Tmax0-7d.
Tmax0-7d - The time from dosing to the maximum observed concentration was taken directly from the plasma concentration-time course profile. If the maximum plasma concentration was observed at 2 or more consecutive time points, the earliest time point was used for Tmax.
Measured: 0 to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2000Mar 2001

First posted13 Dec 2010 (estimated)
Study startNov 2000
Primary completionMar 2001
Study completionMar 2001

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01259102
Sponsor's protocol ID: BUP1002
Status last verified: Aug 2012
First submitted: 10 Dec 2010
Last updated: 3 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Parallel Open-Label Study to Examine Plasma Concentrations of Buprenorphine Following Reapplication of 10-mg Buprenorphine Transdermal System (BTDS) After Variable Application Site Rest Periods in Healthy Subjects
ClinicalTrials.gov ID: NCT01259102
Acronym / sponsor ID: BUP1002
Conditions: Healthy
Keywords: Healthy subjects, Opioid, Transdermal
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Nov 2000
Primary completion: Mar 2001 (actual)
Study completion: Mar 2001 (actual)
First posted: 13 Dec 2010 (estimated)
Results: Posted 7 Feb 2011

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 this study is to determine the pharmacokinetics of BTDS following same-site patch reapplication after rest intervals.

Detailed description

Study design

Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
No Rest	Experimental	Drug: Buprenorphine transdermal patchBTDS 10 with no application site rest period prior to application of second BTDS
7-Day Rest	Experimental	Drug: Buprenorphine transdermal patchBTDS 10 with 7-day rest period prior to application of second BTDS
14-Day Rest	Experimental	Drug: Buprenorphine transdermal patchBTDS 10 with 14-day rest period prior to application of second BTDS
21-Day Rest	Experimental	Drug: Buprenorphine transdermal patchBTDS 10 with 21-day rest period prior to application of second BTDS
28-Day Rest	Experimental	Drug: Buprenorphine transdermal patchBTDS 10 with 28-day rest period prior to application of second BTDS

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Males and females 18 to 45 years of age, inclusive.
Weight of 60 to 100 kilograms (kg) [132-220 pounds (lb)] and within 15% of optimum for height and body frame.
In good health, evidenced by a lack of significantly abnormal findings on medical history, physical examination, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
Willing to discontinue and abstain from any medications, including vitamins or mineral supplements, throughout the study.
Willing to follow dietary restrictions, including abstention from caffeine and xanthine-containing beverages for the duration of the study.

Key exclusion criteria (9 listed)

A history of hypersensitivity to opioid or psychotropic drugs.
A history of recurrent seizures or syncope.
Any medical or surgical conditions which might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs.
Any other significant active medical illness such as: history or presence of liver disease or liver injury that is indicated by an abnormal liver function profile such as aspartate transaminase (AST), alanine transaminase (ALT), or serum bilirubin; history or presence of impaired renal function that is indicated by abnormal creatinine or blood urea nitrogen (BUN) values or abnormal urinary constituents (eg, albuminuria); history of neutropenia (absolute neutrophil count [ANC] <1000/mm3 or thrombocytopenia (platelet <150,000/mm3).
Positive results of urine drug screen or urine cotinine (consistent with active smoking).

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
Buprenorphine transdermal patchAlso: Butrans™Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.	Drug	14-Day Rest, 21-Day Rest, 28-Day Rest, 7-Day Rest, No Rest

Primary outcome

Period 1: AUC0-3d
Time frame: 0 to 3 days (72 hours)
Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d [The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)].
Period 2: AUC0-3d.
Time frame: 0 to 3 days
Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by AUC0-3d. AUC0-3d - The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours).
Period 1: Cmax0-3d
Time frame: 0 to 3 days
Period 1 was the first application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d. Cmax0-3d - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug.
Period 2: Cmax0-3d
Time frame: 0 to 3 days
Period 2 was the second application of BTDS 10: To determine the minimum application site rest periods that ensured that the reapplication of BTDS to the same site in the deltoid region did not result in increased absorption of the drug as measured by Cmax0-3d. Cmax0-3d (pg/mL) - The maximum observed concentration taken directly from the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours). This was considered an index of maximum (peak) exposure to the study drug.

6 secondary outcomes

Period 1: AUC0-7d.
Time frame: 0 to 7 days
Period 2: AUC0-7d
Time frame: 0 to 7 days
Period 1: Cmax0-7
Time frame: 0 to 7 days
Period 2: Cmax0-7d
Time frame: 0 to 7 days
Period 1: Tmax0-7d.
Time frame: 0 to 7days
Period 2: Tmax0-7d.
Time frame: 0 to 7 days

Results and safety

Results posted to the registry on 7 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Rest	13	12
7-Day Rest	14	14
14-Day Rest	15	13
21-Day Rest	14	12
28-Day Rest	14	13

Primary outcome: Period 1: AUC0-3d

Time frame: 0 to 3 days (72 hours). Mean (Standard Error). Unit: pg/mL*h

Measure	No Rest n = 12	7-Day Rest n = 11	14-Day Rest n = 13	21-Day Rest n = 12	28-Day Rest n = 12
Value	8680 (920)	7651 (1514)	6465 (1091)	12258 (836)	8890 (1054)

Population analysed: Pharmacokinetic Population: All subjects who satisfied the inclusion/exclusion criteria, received both applications of BTDS, and submitted to postbaseline phlebotomy through at least the 72-hour time point of both applications.

Primary outcome: Period 2: AUC0-3d.

Time frame: 0 to 3 days. Mean (Standard Error). Unit: pg/mL*h

Measure	No Rest n = 12	7-Day Rest n = 11	14-Day Rest n = 13	21-Day Rest n = 12	28-Day Rest n = 12
Value	12316 (1062)	14733 (2255)	13571 (1671)	12931 (908)	9056 (888)

Primary outcome: Period 1: Cmax0-3d

Time frame: 0 to 3 days. Mean (Standard Error). Unit: pg/mL

Measure	No Rest n = 12	7-Day Rest n = 11	14-Day Rest n = 13	21-Day Rest n = 12	28-Day Rest n = 12
Value	183 (17)	193 (50)	151 (24)	241 (15)	185 (16)

Primary outcome: Period 2: Cmax0-3d

Time frame: 0 to 3 days. Mean (Standard Error). Unit: pg/mL

Measure	No Rest n = 12	7-Day Rest n = 11	14-Day Rest n = 13	21-Day Rest n = 12	28-Day Rest n = 12
Value	216 (17)	300 (52)	262 (31)	278 (41)	182 (14)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events, whether spontaneously reported or elicited on direct questioning, that occurred after administration of the first dose of study drug and on or before the final visit were reported on the adverse event form.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Rest	0 of 13 (0%)	11 of 13 (84.6%)	Not reported
7-Day Rest	1 of 14 (7.1%)	14 of 14 (100%)	Not reported
14-Day Rest	0 of 15 (0%)	13 of 15 (86.7%)	Not reported
21-Day Rest	0 of 14 (0%)	10 of 14 (71.4%)	Not reported
28-Day Rest	0 of 14 (0%)	11 of 14 (78.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Buprenorphine transdermal patch in people with Healthy, run by Purdue Pharma LP 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 6 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 3 Sep 2012. 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?

Yes. Results are posted in the registry (first posted 7 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Period 1: AUC0-3d (time frame: 0 to 3 days (72 hours)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01259102.

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 3 Sep 2012.