NCT01259102

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2001

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
2 months until next milestone

Results Posted

Study results publicly available

February 7, 2011

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

December 10, 2010

Results QC Date

January 13, 2011

Last Update Submit

August 27, 2012

Conditions

Healthy

Keywords

Healthy subjectsOpioidTransdermal

Outcome Measures

Primary Outcomes (4)

  • 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 \[The area under the plasma concentration-time course profile from time = 0 (dosing) through day 3 (to 72 hours)\].

    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).

    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.

    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.

    0 to 3 days

Secondary Outcomes (6)

  • Period 1: AUC0-7d.

    0 to 7 days

  • Period 2: AUC0-7d

    0 to 7 days

  • Period 1: Cmax0-7

    0 to 7 days

  • Period 2: Cmax0-7d

    0 to 7 days

  • Period 1: Tmax0-7d.

    0 to 7days

  • +1 more secondary outcomes

Study Arms (5)

No Rest

EXPERIMENTAL

BTDS 10 with no application site rest period prior to application of second BTDS

Drug: Buprenorphine transdermal patch

7-Day Rest

EXPERIMENTAL

BTDS 10 with 7-day rest period prior to application of second BTDS

Drug: Buprenorphine transdermal patch

14-Day Rest

EXPERIMENTAL

BTDS 10 with 14-day rest period prior to application of second BTDS

Drug: Buprenorphine transdermal patch

21-Day Rest

EXPERIMENTAL

BTDS 10 with 21-day rest period prior to application of second BTDS

Drug: Buprenorphine transdermal patch

28-Day Rest

EXPERIMENTAL

BTDS 10 with 28-day rest period prior to application of second BTDS

Drug: Buprenorphine transdermal patch

Interventions

Buprenorphine transdermal patchDRUG

Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.

Also known as: Butrans™
14-Day Rest21-Day Rest28-Day Rest7-Day RestNo Rest

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Females who are nursing.
  • Females who are pregnant as confirmed by a positive serum human chorionic gonadotropin (bHCG) test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Department of Pharmacology

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Buprenorphine

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Executive Medical Director, Clinical Pharmacology
Organization
Purdue Pharma L.P.
800-733-1333

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2010

First Posted

December 13, 2010

Study Start

November 1, 2000

Primary Completion

March 1, 2001

Study Completion

March 1, 2001

Last Updated

September 3, 2012

Results First Posted

February 7, 2011

Record last verified: 2012-08

Locations

US(1)