Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants (NCT NCT03316976)
NCT ID: NCT03316976
Last Updated: 2019-05-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Results posted on
2019-05-10
Participant Flow
Participants took part in the study at 1 investigative site in China from 22 November 2017 to 08 February 2018.
Healthy Chinese participants were enrolled in this two arm study to receive single oral dose of dexlansoprazole 30 and 60 milligram (mg) delayed-release capsules.
Participant milestones
| Measure |
Group 1: Dexlansoprazole 30 mg
Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
Group 2: Dexlansoprazole 60 mg
Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
Baseline characteristics by cohort
| Measure |
Group 1: Dexlansoprazole 30 mg
n=20 Participants
Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
Group 2: Dexlansoprazole 60 mg
n=20 Participants
Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.4 years
STANDARD_DEVIATION 6.73 • n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
29.4 years
STANDARD_DEVIATION 5.66 • n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
29.4 years
STANDARD_DEVIATION 6.14 • n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Sex: Female, Male
Female
|
12 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
7 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
19 Participants
n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
13 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
21 Participants
n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
20 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
20 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
40 Participants
n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Height
|
165.88 centimeter
STANDARD_DEVIATION 7.688 • n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
167.38 centimeter
STANDARD_DEVIATION 7.720 • n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
166.63 centimeter
STANDARD_DEVIATION 7.642 • n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Weight
|
61.22 kilogram
STANDARD_DEVIATION 8.469 • n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
62.43 kilogram
STANDARD_DEVIATION 8.542 • n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
61.82 kilogram
STANDARD_DEVIATION 8.418 • n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Body Mass Index (BMI)
|
22.17 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.808 • n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
22.22 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.911 • n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
22.20 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.836 • n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Smoking Classification
Never smoked
|
15 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
17 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
32 Participants
n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Smoking Classification
Ex-Smoker
|
5 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
3 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
8 Participants
n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Caffeine Consumption Status 72 hours Prior to Check-in (Day -1)
Had caffeine consumption
|
0 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
0 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
0 Participants
n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Caffeine Consumption Status 72 hours Prior to Check-in (Day -1)
Had no caffeine consumption
|
20 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
20 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
40 Participants
n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Alcohol Consumption Status 7 Days Prior to Check-in (Day -1)
Had alcohol consumption
|
0 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
0 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
0 Participants
n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Alcohol Consumption Status 7 Days Prior to Check-in (Day -1)
Had no alcohol consumption
|
20 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
20 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
40 Participants
n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Drug Abuse/Addiction
Had a history of drug abuse/addiction
|
0 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
0 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
0 Participants
n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
|
Drug Abuse/Addiction
Had no history of drug abuse/addiction
|
20 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
20 Participants
n=20 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
40 Participants
n=40 Participants • The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dosePopulation: The pharmacokinetics (PK) set included all participants who received at least 1 dose of study drug and had at least 1 measureable plasma concentration of dexlansoprazole.
Outcome measures
| Measure |
Group 1: Dexlansoprazole 30 mg
n=20 Participants
Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
Group 2: Dexlansoprazole 60 mg
n=20 Participants
Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
|
732 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 43.73
|
1756 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 45.83
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dosePopulation: The PK set included all participants who received at least 1 dose of study drug and had at least 1 measureable plasma concentration of dexlansoprazole.
Outcome measures
| Measure |
Group 1: Dexlansoprazole 30 mg
n=20 Participants
Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
Group 2: Dexlansoprazole 60 mg
n=20 Participants
Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole
|
3660 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 61.38
|
10198 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 61.09
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dosePopulation: The PK set included all participants who received at least 1 dose of study drug and had at least 1 measureable plasma concentration of dexlansoprazole.
Outcome measures
| Measure |
Group 1: Dexlansoprazole 30 mg
n=20 Participants
Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
Group 2: Dexlansoprazole 60 mg
n=20 Participants
Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole
|
3701 h*ng/mL
Geometric Coefficient of Variation 62.83
|
10340 h*ng/mL
Geometric Coefficient of Variation 64.20
|
Adverse Events
Group 1: Dexlansoprazole 30 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2: Dexlansoprazole 60 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Dexlansoprazole 30 mg
n=20 participants at risk
Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
Group 2: Dexlansoprazole 60 mg
n=20 participants at risk
Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Baseline up to 30 days after last dose (Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • Baseline up to 30 days after last dose (Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • Baseline up to 30 days after last dose (Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Baseline up to 30 days after last dose (Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • Baseline up to 30 days after last dose (Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Baseline up to 30 days after last dose (Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cells urine
|
5.0%
1/20 • Baseline up to 30 days after last dose (Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • Baseline up to 30 days after last dose (Day 31)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
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 from or any data, information or materials obtained or generated in the performance of its 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