Trial Outcomes & Findings for A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810) (NCT NCT01202071)
NCT ID: NCT01202071
Last Updated: 2012-11-30
Results Overview
The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Day 5 of administration during Period I-IV
Results posted on
2012-11-30
Participant Flow
This study was recruited at 1 center in Japan during the period of 14-Sep-2010 to 2-Dec-2010.
Participant milestones
| Measure |
Group A: Rapeprazole 5 mg, Then 10 mg, Then 20 mg, Then 40 mg
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Period I (9 days total): 5 mg; Period II (8 days total): 10 mg; Period III (8 days total): 20 mg; Period IV (8 days total): 40 mg
Each Period was separated by a \>= 6 day washout period.
Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge.
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Group B: Rapeprazole 10 mg, Then 20 mg, Then 40 mg, Then 5 mg
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Period I (9 days total): 10 mg; Period II (8 days total): 20 mg; Period III (8 days total): 40 mg; Period IV (8 days total): 5 mg
Each Period was separated by a \>= 6 day washout period.
Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge.
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Group C: Rapeprazole 20 mg, Then 40 mg, Then 5 mg, Then 10 mg
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Period I (9 days total): 20 mg; Period II (8 days total): 40 mg; Period III (8 days total): 5 mg; Period IV (8 days total): 10 mg
Each Period was separated by a \>= 6 day washout period.
Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge.
|
Group D: Rapeprazole 40 mg, Then 5 mg, Then 10 mg, Then 20 mg
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Period I (9 days total): 40 mg; Period II (8 days total): 5 mg; Period III (8 days total): 10 mg; Period IV (8 days total): 20 mg
Each Period was separated by a \>= 6 day washout period.
Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge.
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Overall Study
STARTED
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6
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6
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6
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6
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Overall Study
COMPLETED
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6
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6
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6
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6
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Overall Study
NOT COMPLETED
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
Baseline characteristics by cohort
| Measure |
Entire Study Population: Group A, Group B, Group C, Group D
n=24 Participants
Includes Group A, Group B, Group C, and Group D. Participants received Rabeprazole sodium Tablets for 5 days in each period.
Group A Period I: 5 mg, Period II: 10 mg, Period III: 20 mg, Period IV: 40 mg
Group B Period I: 10 mg, Period II: 20 mg, Period III: 40 mg, Period IV: 5 mg
Group C Period I: 20 mg, Period II: 40 mg, Period III: 5 mg, Period IV: 10 mg
Group D Period I: 40 mg, Period II: 5 mg, Period III: 10 mg, Period IV: 20 mg
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV, a washout period consisted of 6 days or longer between each period.
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Age Continuous
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27.7 years
STANDARD_DEVIATION 4.5 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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24 Participants
n=5 Participants
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Baseline Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours on Day 1
CYP2C19 Extensive Metabolizers 'EM'
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12.57 Percentage of Time in a 24 Hour Period
STANDARD_DEVIATION 7.55 • n=5 Participants
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Baseline Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours on Day 1
CYP2C19 Poor Metabolizers 'PM'
|
9.91 Percentage of Time in a 24 Hour Period
STANDARD_DEVIATION 8.50 • n=5 Participants
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PRIMARY outcome
Timeframe: Day 5 of administration during Period I-IVThe 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.
Outcome measures
| Measure |
Rabeprazole Sodium 5 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 5 mg was received by:
Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II
|
Rabeprazole Sodium 10 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 10 mg was received by:
Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III
|
Rabeprazole Sodium 20 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 20 mg was received by:
Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV
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Rabeprazole Sodium 40 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 40 mg was received by:
Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I
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|---|---|---|---|---|
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Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration
CYP2C19 Extensive Metabolizers 'EM' (n=16)
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45.63 Percentage of Time in a 24 Hour Period
Standard Deviation 19.17
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57.81 Percentage of Time in a 24 Hour Period
Standard Deviation 12.93
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61.36 Percentage of Time in a 24 Hour Period
Standard Deviation 9.72
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71.52 Percentage of Time in a 24 Hour Period
Standard Deviation 12.20
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Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration
CYP2C19 Poor Metabolizers 'PM' (n=8)
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62.51 Percentage of Time in a 24 Hour Period
Standard Deviation 14.79
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71.83 Percentage of Time in a 24 Hour Period
Standard Deviation 14.64
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75.74 Percentage of Time in a 24 Hour Period
Standard Deviation 20.62
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83.08 Percentage of Time in a 24 Hour Period
Standard Deviation 11.13
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SECONDARY outcome
Timeframe: Day 1 and Day 5 of administration during Period I-IVPharmacokinetic parameter: maximal drug concentration (Cmax) measured in nanograms per milliliter (ng/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.
Outcome measures
| Measure |
Rabeprazole Sodium 5 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 5 mg was received by:
Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II
|
Rabeprazole Sodium 10 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 10 mg was received by:
Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III
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Rabeprazole Sodium 20 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 20 mg was received by:
Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV
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Rabeprazole Sodium 40 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 40 mg was received by:
Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I
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Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)
Day 1: CYP2C19 Extensive Metabolizers 'EM' (n=16)
|
137.7 ng/mL
Standard Deviation 55.7
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253.6 ng/mL
Standard Deviation 120.2
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520.0 ng/mL
Standard Deviation 267.7
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1007.6 ng/mL
Standard Deviation 513.1
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Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)
Day 5: CYP2C19 Extensive Metabolizers 'EM' (n=16)
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146.0 ng/mL
Standard Deviation 56.4
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382.8 ng/mL
Standard Deviation 82.9
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654.1 ng/mL
Standard Deviation 348.4
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1018.5 ng/mL
Standard Deviation 516.9
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Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)
Day 1: CYP2C19 Poor Metabolizers 'PM' (n=8)
|
185.1 ng/mL
Standard Deviation 79.0
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434.7 ng/mL
Standard Deviation 98.5
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891.9 ng/mL
Standard Deviation 210.8
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1574.2 ng/mL
Standard Deviation 596.6
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Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)
Day 5: CYP2C19 Poor Metabolizers 'PM' (n=8)
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251.9 ng/mL
Standard Deviation 55.1
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508.5 ng/mL
Standard Deviation 63.8
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821.9 ng/mL
Standard Deviation 231.7
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1986.5 ng/mL
Standard Deviation 439.1
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SECONDARY outcome
Timeframe: Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose)Pharmacokinetic parameter: Area under the plasma concentration-time curve from time 0 (administration of the drug) to time t (the last quantifiable concentration time point). AUC measured in nanogram hours per milliliter (ng\*h/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.
Outcome measures
| Measure |
Rabeprazole Sodium 5 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 5 mg was received by:
Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II
|
Rabeprazole Sodium 10 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 10 mg was received by:
Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III
|
Rabeprazole Sodium 20 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 20 mg was received by:
Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV
|
Rabeprazole Sodium 40 mg Tablet
n=24 Participants
Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.
Rabeprazole sodium 40 mg was received by:
Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I
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|---|---|---|---|---|
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Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])
Day 1: CYP2C19 Extensive Metabolizers 'EM' (n=16)
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215.5 ng*h/mL
Standard Deviation 88.4
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429.7 ng*h/mL
Standard Deviation 209.4
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866.9 ng*h/mL
Standard Deviation 385.6
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1807.2 ng*h/mL
Standard Deviation 949.2
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Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])
Day 5: CYP2C19 Extensive Metabolizers 'EM' (n=16)
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235.7 ng*h/mL
Standard Deviation 97.1
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539.1 ng*h/mL
Standard Deviation 199.6
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993.7 ng*h/mL
Standard Deviation 476.9
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1929.6 ng*h/mL
Standard Deviation 884.1
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Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])
Day 1: CYP2C19 Poor Metabolizers 'PM' (n=8)
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455.0 ng*h/mL
Standard Deviation 137.7
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1029.6 ng*h/mL
Standard Deviation 293.9
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2112.9 ng*h/mL
Standard Deviation 628.8
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4002.3 ng*h/mL
Standard Deviation 1216.0
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Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])
Day 5: CYP2C19 Poor Metabolizers 'PM' (n=8)
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584.6 ng*h/mL
Standard Deviation 137.1
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1230.4 ng*h/mL
Standard Deviation 200.0
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2330.6 ng*h/mL
Standard Deviation 662.9
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4627.9 ng*h/mL
Standard Deviation 1296.0
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Adverse Events
Rabeprazole Sodium 5 mg Tablet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rabeprazole Sodium 10 mg Tablet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rabeprazole Sodium 20 mg Tablet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rabeprazole Sodium 40 mg Tablet
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