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Pharmacokinetic Profile of Myfortic in Combination With Tacrolimus in Fed Versus Fasting State

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ClinicalTrials.gov Identifier: NCT00585468
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : May 6, 2016
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Transplantation
Intervention Drug: Myfortic
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fed State First, Then Fasting State Fasting State First, Then Fed State
Hide Arm/Group Description 720 milligrams (mg) mycophenolate sodium orally twice daily with a meal for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily separated by food by 2 hours in the second intervention period. 720 mg mycophenolate sodium orally twice daily separated from food by 2 hours for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily with a meal in the second intervention period.
Period Title: First Intervention
Started 10 11
Completed 9 10
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Period Title: Second Intervention
Started 9 10
Completed 9 10
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes groups randomized to the Fed State first and to the Fasted State first
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
43.6  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
6
  28.6%
Male
15
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid (MPA)
Hide Description [Not Specified]
Time Frame 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic - Fed State Myfortic - Fasting State
Hide Arm/Group Description:
Mycophenolate sodium taken with a meal
Mycophenolate sodium taken separately from food by 2 hours
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter
12.8  (6.7) 18.7  (7.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic - Fed State, Myfortic - Fasting State
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0163
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid (MPA)
Hide Description [Not Specified]
Time Frame 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic - Fed State Myfortic - Fasting State
Hide Arm/Group Description:

Mycophenolate sodium taken with a meal.

Myfortic: Myfortic 720 mg orally twice daily

Mycophenolate sodium taken separately from food by 2 hours.

Myfortic: Myfortic 720 mg orally twice daily

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter
2.2  (0.6) 1.7  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic - Fed State, Myfortic - Fasting State
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid (MPA)
Hide Description [Not Specified]
Time Frame 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic - Fed State Myfortic - Fasting State
Hide Arm/Group Description:

Mycophenolate sodium taken with a meal.

Myfortic: Myfortic 720 mg orally twice daily

Mycophenolate sodium taken separately from food by 2 hours.

Myfortic: Myfortic 720 mg orally twice daily

Overall Number of Participants Analyzed 19 19
Median (Full Range)
Unit of Measure: hours
5
(0 to 10)
3
(0 to 8)
4.Primary Outcome
Title Area Under the Curve (AUC) From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid (MPA)
Hide Description AUC (0-12) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose, measured in microgram-hours per milliliter (mcg*h/mL)
Time Frame 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic - Fed State Myfortic - Fasting State
Hide Arm/Group Description:

Mycophenolate sodium taken with a meal.

Myfortic: Myfortic 720 mg orally twice daily

Mycophenolate sodium taken separately from food by 2 hours.

Myfortic: Myfortic 720 mg orally twice daily

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: mcg*h/mL
56.5  (15.2) 63.9  (15.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic - Fed State, Myfortic - Fasting State
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.146
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid Glucuronide (MPAG)
Hide Description [Not Specified]
Time Frame 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic - Fed State Myfortic - Fasting State
Hide Arm/Group Description:

Mycophenolate sodium taken with a meal.

Myfortic: Myfortic 720 mg orally twice daily

Mycophenolate sodium taken separately from food by 2 hours.

Myfortic: Myfortic 720 mg orally twice daily

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter
104.9  (35.7) 113.0  (36.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic - Fed State, Myfortic - Fasting State
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4937
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Primary Outcome
Title Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid Glucuronide (MPAG)
Hide Description [Not Specified]
Time Frame 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic - Fed State Myfortic - Fasting State
Hide Arm/Group Description:

Mycophenolate sodium taken with a meal.

Myfortic: Myfortic 720 mg orally twice daily

Mycophenolate sodium taken separately from food by 2 hours.

Myfortic: Myfortic 720 mg orally twice daily

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter
59.4  (24.9) 57.0  (23.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic - Fed State, Myfortic - Fasting State
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9669
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Primary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid Glucuronide (MPAG)
Hide Description [Not Specified]
Time Frame 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic - Fed State Myfortic - Fasting State
Hide Arm/Group Description:

Mycophenolate sodium taken with a meal.

Myfortic: Myfortic 720 mg orally twice daily

Mycophenolate sodium taken separately from food by 2 hours.

Myfortic: Myfortic 720 mg orally twice daily

Overall Number of Participants Analyzed 19 19
Median (Full Range)
Unit of Measure: hours
3
(0 to 11)
3
(1 to 7)
8.Primary Outcome
Title Area Under the Curve From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid Glucuronide (MPAG)
Hide Description AUC (0-12) = Area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose, measured in microgram-hours per milliliter (mcg*h/mL)
Time Frame 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Myfortic - Fed State Myfortic - Fasting State
Hide Arm/Group Description:

Mycophenolate sodium taken with a meal.

Myfortic: Myfortic 720 mg orally twice daily

Mycophenolate sodium taken separately from food by 2 hours.

Myfortic: Myfortic 720 mg orally twice daily

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: mcg*h/mL
967.5  (364.0) 962.2  (289.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myfortic - Fed State, Myfortic - Fasting State
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9607
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not collected in this study
 
Arm/Group Title Myfortic - Fed State Myfortic - Fasting State
Hide Arm/Group Description Mycophenolate sodium taken with a meal Mycophenolate sodium taken separately from food by 2 hours
All-Cause Mortality
Myfortic - Fed State Myfortic - Fasting State
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Myfortic - Fed State Myfortic - Fasting State
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Myfortic - Fed State Myfortic - Fasting State
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fuad Shihab, MD
Organization: University of Utah
Phone: 801-585-3823
EMail: fuad.shihab@hsc.utah.edu
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585468     History of Changes
Other Study ID Numbers: 15121
Award# CERL080AUS33 ( Other Grant/Funding Number: Novartis Pharmaceuticals )
First Submitted: December 21, 2007
First Posted: January 3, 2008
Results First Submitted: September 10, 2013
Results First Posted: May 6, 2016
Last Update Posted: May 6, 2016