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Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Colchicine 0.6 mg tablet
Colchicine 0.6 mg tablet
Sponsored by
Mutual Pharmaceutical Company, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring bioavailability

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults age 18-55, non-smoking, non- pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index of 18-30 kg/m²

Exclusion Criteria:

  • Recent participation (within 30 days) in other research studies
  • Recent significant blood donation or plasma donation
  • Pregnant or lactating
  • Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
  • History of treatment for drug or alcohol addiction within the previous 12 months or use of tobacco products within 90 days of the start of the study
  • Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders (angina, heart failure, irregular heartbeats, heart attack, hypertension, hypotension) stroke, renal or hepatic disorders, diabetes or bleeding disorders, gastrointestinal disease or history of malabsorption within the last year
  • History of psychiatric disorders occurring within the last two years that required hospitalization or medication
  • Presence of a medical condition requiring regular treatment with prescription drugs
  • Use of any drugs or substances known to inhibit or induce drug-metabolizing enzymes within 30 days prior to dosing with the study drug
  • Drug allergies or sensitivity to colchicine
  • Positive test results for drugs of abuse at screening

Sites / Locations

  • Novum Pharmaceutical Research Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Colcrys® 0.6 mg intact tablet

Colcrys® 0.6 mg tablet on applesauce

Arm Description

One Colcrys® 0.6 mg intact tablet taken by mouth

One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration (Cmax)
The maximum or peak concentration that Colcrys® reaches in the plasma
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2010
Last Updated
May 10, 2011
Sponsor
Mutual Pharmaceutical Company, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01130051
Brief Title
Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce
Official Title
A Pilot Bioavailability Study of Colcrys® Tablet 0.6 mg Versus Colcrys® Tablets 0.6 mg Crushed and Sprinkled on Applesauce Under Fasting Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mutual Pharmaceutical Company, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1 tablespoon) relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. A secondary objective is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the study period.
Detailed Description
The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and sprinkled on applesauce (1 tablespoon) relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. Sixteen healthy, non-smoking, non-obese, male and female volunteers between 18-55 years of age will be randomly assigned in a crossover fashion to receive each of two dosing regimens in sequence with a 14 day washout period between dosing periods. In each of the dosing periods, after an overnight fast, subjects will receive one intact Colcrys® 0.6 mg tablet (followed by 240 mL of water) or one Colcrys® 0.6 mg tablet crushed and sprinkled on 1 tablespoon of applesauce (followed by 240 ml of water) according to the randomization schedule. Blood samples will be drawn from all participants before dosing and for 48 hours post-dose at times sufficient to adequately define the pharmacokinetics of colchicine. Vital signs (blood pressure, heart rate, respiratory rate and temperature) will be measured prior to dosing, 1 hour ± 30 minutes post-dose and upon discharge from the clinical facility. Subjects will be monitored throughout their participation in the study for adverse reactions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
bioavailability

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colcrys® 0.6 mg intact tablet
Arm Type
Experimental
Arm Description
One Colcrys® 0.6 mg intact tablet taken by mouth
Arm Title
Colcrys® 0.6 mg tablet on applesauce
Arm Type
Experimental
Arm Description
One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.6 mg tablet
Other Intervention Name(s)
Colcrys®
Intervention Description
One Colcrys® 0.6 mg intact tablet taken by mouth
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.6 mg tablet
Other Intervention Name(s)
Colcrys®
Intervention Description
One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)
Description
The maximum or peak concentration that Colcrys® reaches in the plasma
Time Frame
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration
Title
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
Description
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable Colcrys® concentration (t), as calculated by the linear trapezoidal rule
Time Frame
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration
Title
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]
Description
The area under the plasma concentration versus time curve from time 0 to infinity. AUC (0-∞) was calculated as the sum of AUC (0-t) plus the ratio of the last measurable Colcrys® plasma concentration to the elimination rate constant.
Time Frame
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.25, 0.5, 1.0, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 20, 24, 36, and 48 hours after drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults age 18-55, non-smoking, non- pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index of 18-30 kg/m² Exclusion Criteria: Recent participation (within 30 days) in other research studies Recent significant blood donation or plasma donation Pregnant or lactating Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) History of treatment for drug or alcohol addiction within the previous 12 months or use of tobacco products within 90 days of the start of the study Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders (angina, heart failure, irregular heartbeats, heart attack, hypertension, hypotension) stroke, renal or hepatic disorders, diabetes or bleeding disorders, gastrointestinal disease or history of malabsorption within the last year History of psychiatric disorders occurring within the last two years that required hospitalization or medication Presence of a medical condition requiring regular treatment with prescription drugs Use of any drugs or substances known to inhibit or induce drug-metabolizing enzymes within 30 days prior to dosing with the study drug Drug allergies or sensitivity to colchicine Positive test results for drugs of abuse at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Davis, M.D.
Organizational Affiliation
Mutual Pharmaceutical Company, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Novum Pharmaceutical Research Services
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States

12. IPD Sharing Statement

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Bioavailability Study of Colcrys® Crushed and Sprinkled on Applesauce

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