Trial Outcomes & Findings for Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease (NCT NCT00847210)
NCT ID: NCT00847210
Last Updated: 2012-02-02
Results Overview
Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7.
COMPLETED
PHASE1
36 participants
After 7 days of dosing.
2012-02-02
Participant Flow
Participants were enrolled at 3 investigative sites in the United States from 31 May 2009 to 10 September 2009.
Participants were enrolled in one of two, dexlansoprazole modified release (MR), once-daily (QD) treatment groups. 100% of participants randomized completed this study.
Participant milestones
| Measure |
Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease
Baseline characteristics by cohort
| Measure |
Dexlansoprazole MR 30 mg QD
n=18 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|
Dexlansoprazole MR 60 mg QD
n=18 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
14.6 years
STANDARD_DEVIATION 1.65 • n=99 Participants
|
14.6 years
STANDARD_DEVIATION 1.89 • n=107 Participants
|
14.6 years
STANDARD_DEVIATION 1.75 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
18 participants
n=107 Participants
|
36 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: After 7 days of dosing.Population: All participants who had Tmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the pharmacokinetic (PK) analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.
Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7.
Outcome measures
| Measure |
Dexlansoprazole MR 30 mg QD
n=17 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|
Dexlansoprazole MR 60 mg QD
n=18 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
|
|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
|
4.65 hours
Standard Deviation 2.909
|
3.31 hours
Standard Deviation 1.519
|
PRIMARY outcome
Timeframe: After 7 days of dosing.Population: All participants who had Cmax estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.
Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Dexlansoprazole MR 30 mg QD
n=17 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|
Dexlansoprazole MR 60 mg QD
n=18 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.
|
691 ng/mL
Standard Deviation 367.5
|
1136 ng/mL
Standard Deviation 582.2
|
PRIMARY outcome
Timeframe: After 7 days of dosing.Population: All participants who had AUC(0-tlqc) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.
Area Under the Plasma Concentration Versus Time Curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Outcome measures
| Measure |
Dexlansoprazole MR 30 mg QD
n=17 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|
Dexlansoprazole MR 60 mg QD
n=18 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
|
|---|---|---|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.
|
2842.32 ng*hr/mL/mg
Standard Deviation 1313.827
|
5113.72 ng*hr/mL/mg
Standard Deviation 2987.508
|
PRIMARY outcome
Timeframe: After 7 days of dosing.Population: All participants who had AUC(0-24) estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values.
AUC(0-24) is measure of Area Under the Curve over the dosing interval (tau) (AUC(0-tau\]), where tau is the length of the dosing interval - 24 hours in this study).
Outcome measures
| Measure |
Dexlansoprazole MR 30 mg QD
n=16 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|
Dexlansoprazole MR 60 mg QD
n=18 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
|
|---|---|---|
|
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.
|
2886.26 ng*hr/mL/mg
Standard Deviation 1355.182
|
5119.81 ng*hr/mL/mg
Standard Deviation 2986.453
|
PRIMARY outcome
Timeframe: After 7 days of dosing.Population: All participants who had T1/2 estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. No statistical tests were performed.
Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Outcome measures
| Measure |
Dexlansoprazole MR 30 mg QD
n=16 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|
Dexlansoprazole MR 60 mg QD
n=18 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
|
|---|---|---|
|
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.
|
1.66 hours
Standard Deviation 0.871
|
2.59 hours
Standard Deviation 1.379
|
PRIMARY outcome
Timeframe: After 7 days of dosing.Population: All participants who had CL/F estimated were included in the analysis. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr.
Outcome measures
| Measure |
Dexlansoprazole MR 30 mg QD
n=16 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|
Dexlansoprazole MR 60 mg QD
n=18 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
|
|---|---|---|
|
Oral Clearance (CL/F) Pharmacokinetic Parameter.
|
12.81 liter/hr
Standard Deviation 6.092
|
15.29 liter/hr
Standard Deviation 7.524
|
PRIMARY outcome
Timeframe: After 7 days of dosing.Population: All participants who had λz estimated were included in the analysis. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.
Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body.
Outcome measures
| Measure |
Dexlansoprazole MR 30 mg QD
n=16 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|
Dexlansoprazole MR 60 mg QD
n=18 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
|
|---|---|---|
|
Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.
|
0.5264 1/hr
Standard Deviation 0.25425
|
0.3404 1/hr
Standard Deviation 0.17406
|
PRIMARY outcome
Timeframe: After 7 days of dosing.Population: All participants who had Vz/F estimated were included in the analysis for this parameter. One participant in the 30 mg group was excluded from the PK analysis because most of the PK samples were not collected, and hence no PK parameters were estimable. There was no imputation for missing values. No statistical tests were performed.
Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.
Outcome measures
| Measure |
Dexlansoprazole MR 30 mg QD
n=16 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|
Dexlansoprazole MR 60 mg QD
n=18 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.
|
28.90 L
Standard Deviation 21.208
|
58.50 L
Standard Deviation 46.100
|
Adverse Events
Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR 60 mg QD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexlansoprazole MR 30 mg QD
n=18 participants at risk
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
|
Dexlansoprazole MR 60 mg QD
n=18 participants at risk
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
5.6%
1/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
5.6%
1/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
22.2%
4/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
0.00%
0/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
11.1%
2/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
|
General disorders
Feelings of Body Temperature Change
|
0.00%
0/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
5.6%
1/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
5.6%
1/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
11.1%
2/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
5.6%
1/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
5.6%
1/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
0.00%
0/18 • Treatment-emergent adverse events are defined as those reported after the first dose and no more than 30 days after the last dose of study drug.
There were no deaths, serious adverse events or significant adverse events during the study.
|
Additional Information
Sr. VP Clinical Science
Takeda Global Research and Development Center, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights therefrom or any data, information or materials obtained or generated in the performance of it's obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER