NCT01309425

Brief Summary

The purpose of this study is to evaluate the dose-proportionality of the pharmacokinetics of tapentadol (CG5503) in healthy Japanese and Korean adult male participants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_1

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

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

January 31, 2014

Status Verified

October 1, 2012

First QC Date

March 3, 2011

Last Update Submit

January 30, 2014

Conditions

Healthy Volunteer

Keywords

tapentadolNUCYNTACG5503R331333pharmacokineticshealthy volunteer

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic profile, as measured by Cmax, AUC, tmax, kel, t1/2

    Two days

Secondary Outcomes (1)

  • Number of participants with adverse events

    Time of screening to end of treatment (up to 9.5 weeks)

Study Arms (4)

001

EXPERIMENTAL

tapentadol (CG5503) ER 25-mg TRF 25mg TRF single oral dose

Drug: tapentadol (CG5503) ER 25-mg TRF

002

EXPERIMENTAL

tapentadol (CG5503) ER 50-mg TRF 50mg TRF single oral dose

Drug: tapentadol (CG5503) ER 50-mg TRF

003

EXPERIMENTAL

tapentadol (CG5503) ER 100-mg TRF 100mg TRF single oral dose

Drug: tapentadol (CG5503) ER 100-mg TRF

004

EXPERIMENTAL

tapentadol (CG5503) ER two 100-mg TRF 200mg TRF single oral dose

Drug: tapentadol (CG5503) ER two 100-mg TRF

Interventions

tapentadol (CG5503) ER two 100-mg TRFDRUG

200mg TRF single oral dose

004
tapentadol (CG5503) ER 50-mg TRFDRUG

50mg TRF single oral dose

002
tapentadol (CG5503) ER 25-mg TRFDRUG

25mg TRF single oral dose

001
tapentadol (CG5503) ER 100-mg TRFDRUG

100mg TRF single oral dose

003

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Japanese and Korean male volunteers, inclusive
  • Body mass index (BMI) between 18.5 and 25 kg/m², inclusive, and a body weight of not less than 50 kg
  • Japanese volunteers must have resided outside of Japan for no more than 5 years, and their parents and maternal and paternal grandparents are Japanese.
  • Korean volunteers must have resided outside of Korea for no more than 5 years and their parents and maternal and paternal grandparents are Korean.

You may not qualify if:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease
  • History of hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities
  • History of significant pulmonary disease, including bronchospastic respiratory disease
  • History of diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol-acetaminophen, within 14 days before the first dose of the study drug is scheduled
  • History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tapentadol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 7, 2011

Study Start

February 1, 2011

Study Completion

May 1, 2011

Last Updated

January 31, 2014

Record last verified: 2012-10