NCT01551797

Brief Summary

This proof of principle study will evaluate an experimental formulation of paracetamol that is being developed for eventual long lasting use. This study is also used for drug safety evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started May 2010

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

May 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
Last Updated

December 10, 2012

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

February 23, 2012

Last Update Submit

December 6, 2012

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Median time to reach therapeutic plasma concentration of paracetamol

    Time period in hours over which plasma paracetamol concentration is elevated at or above 4 micrograms (μg)/milliliter (mL).

    Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

Secondary Outcomes (6)

  • Area under the plasma concentration-time curve (AUC)

    Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

  • Time to maximum plasma concentration (Tmax)

    Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

  • Half-life of elimination (T 1/2)

    Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

  • Elimination rate (Kel)

    Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

  • Maximum plasma concentration (Cmax)

    Baseline, 15 min, 30 min, 45 min, 1, 1.5 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 14, 15, 16, and 18 hours post-treatment

  • +1 more secondary outcomes

Study Arms (3)

Test Sustained Release (SR) Paracetamol (2000 mg)

EXPERIMENTAL

A single 2000 mg oral dose of SR paracetamol formulation (2 x 1000 mg) administered with 150 mL of water.

Drug: Paracetamol 1000 mg

Test SR Paracetamol (1500 mg)

EXPERIMENTAL

A single 1500 mg oral dose of SR paracetamol formulation (2 x 750 mg) administered with 150 mL of water.

Drug: Paracetamol 750 mg

Reference Paracetamol (2000 mg)

ACTIVE COMPARATOR

Two single 1000 mg doses of paracetamol (2 x 500 mg/dose) administered orally 6 hours apart, administered with 150 mL of water.

Drug: Paracetamol 500 mg

Interventions

Paracetamol 500 mgDRUG

Standard Paracetamol formulation

Reference Paracetamol (2000 mg)
Paracetamol 1000 mgDRUG

Paracetamol Sustained Release formulation

Test Sustained Release (SR) Paracetamol (2000 mg)
Paracetamol 750 mgDRUG

Paracetamol Sustained Release formulation

Test SR Paracetamol (1500 mg)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index (BMI): Body Mass Index must be in the range 19-28 kg/m2.

You may not qualify if:

  • Disease: Current or recurrent disease that could affect the action, absorption, elimination or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders evidenced by abnormal liver function test, hepatitis serology test and liver image studies, renal insufficiency, congestive heart failure).
  • Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles River Clinical Services Northwest, Inc.

Tacoma, Washington, 98481, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 23, 2012

First Posted

March 13, 2012

Study Start

May 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

December 10, 2012

Record last verified: 2012-11

Locations

US(1)