Trial Outcomes & Findings for Pharmacokinetic Profile of Myfortic in Combination With Tacrolimus in Fed Versus Fasting State (NCT NCT00585468)
NCT ID: NCT00585468
Last Updated: 2016-05-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose
Results posted on
2016-05-06
Participant Flow
Participant milestones
| Measure |
Fed State First, Then Fasting State
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.
|
Fasting State First, Then Fed State
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.
|
|---|---|---|
|
First Intervention
STARTED
|
10
|
11
|
|
First Intervention
COMPLETED
|
9
|
10
|
|
First Intervention
NOT COMPLETED
|
1
|
1
|
|
Second Intervention
STARTED
|
9
|
10
|
|
Second Intervention
COMPLETED
|
9
|
10
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fed State First, Then Fasting State
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.
|
Fasting State First, Then Fed State
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.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Pharmacokinetic Profile of Myfortic in Combination With Tacrolimus in Fed Versus Fasting State
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=21 Participants
Includes groups randomized to the Fed State first and to the Fasted State first
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 9.8 • n=39 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-doseOutcome measures
| Measure |
Myfortic - Fed State
n=19 Participants
Mycophenolate sodium taken with a meal
|
Myfortic - Fasting State
n=19 Participants
Mycophenolate sodium taken separately from food by 2 hours
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid (MPA)
|
12.8 micrograms per milliliter
Standard Deviation 6.7
|
18.7 micrograms per milliliter
Standard Deviation 7.7
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-doseOutcome measures
| Measure |
Myfortic - Fed State
n=19 Participants
Mycophenolate sodium taken with a meal
|
Myfortic - Fasting State
n=19 Participants
Mycophenolate sodium taken separately from food by 2 hours
|
|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid (MPA)
|
2.2 micrograms per milliliter
Standard Deviation 0.6
|
1.7 micrograms per milliliter
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-doseOutcome measures
| Measure |
Myfortic - Fed State
n=19 Participants
Mycophenolate sodium taken with a meal
|
Myfortic - Fasting State
n=19 Participants
Mycophenolate sodium taken separately from food by 2 hours
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid (MPA)
|
5 hours
Interval 0.0 to 10.0
|
3 hours
Interval 0.0 to 8.0
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-doseAUC (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)
Outcome measures
| Measure |
Myfortic - Fed State
n=19 Participants
Mycophenolate sodium taken with a meal
|
Myfortic - Fasting State
n=19 Participants
Mycophenolate sodium taken separately from food by 2 hours
|
|---|---|---|
|
Area Under the Curve (AUC) From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid (MPA)
|
56.5 mcg*h/mL
Standard Deviation 15.2
|
63.9 mcg*h/mL
Standard Deviation 15.5
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-doseOutcome measures
| Measure |
Myfortic - Fed State
n=19 Participants
Mycophenolate sodium taken with a meal
|
Myfortic - Fasting State
n=19 Participants
Mycophenolate sodium taken separately from food by 2 hours
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Mycophenolic Acid Glucuronide (MPAG)
|
104.9 micrograms per milliliter
Standard Deviation 35.7
|
113.0 micrograms per milliliter
Standard Deviation 36.5
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-doseOutcome measures
| Measure |
Myfortic - Fed State
n=19 Participants
Mycophenolate sodium taken with a meal
|
Myfortic - Fasting State
n=19 Participants
Mycophenolate sodium taken separately from food by 2 hours
|
|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin) of Mycophenolic Acid Glucuronide (MPAG)
|
59.4 micrograms per milliliter
Standard Deviation 24.9
|
57.0 micrograms per milliliter
Standard Deviation 23.0
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-doseOutcome measures
| Measure |
Myfortic - Fed State
n=19 Participants
Mycophenolate sodium taken with a meal
|
Myfortic - Fasting State
n=19 Participants
Mycophenolate sodium taken separately from food by 2 hours
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mycophenolic Acid Glucuronide (MPAG)
|
3 hours
Interval 0.0 to 11.0
|
3 hours
Interval 1.0 to 7.0
|
PRIMARY outcome
Timeframe: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-doseAUC (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)
Outcome measures
| Measure |
Myfortic - Fed State
n=19 Participants
Mycophenolate sodium taken with a meal
|
Myfortic - Fasting State
n=19 Participants
Mycophenolate sodium taken separately from food by 2 hours
|
|---|---|---|
|
Area Under the Curve From Time Zero to 12 Hours Post-Dose [AUC (0-12)] of Mycophenolic Acid Glucuronide (MPAG)
|
967.5 mcg*h/mL
Standard Deviation 364.0
|
962.2 mcg*h/mL
Standard Deviation 289.6
|
Adverse Events
Myfortic - Fed State
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Myfortic - Fasting State
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place