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A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants

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ClinicalTrials.gov Identifier: NCT03316976
Recruitment Status : Completed
First Posted : October 23, 2017
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Volunteers
Intervention Drug: Dexlansoprazole
Enrollment 40
Recruitment Details Participants took part in the study at 1 investigative site in China from 22 November 2017 to 08 February 2018.
Pre-assignment Details 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.
Arm/Group Title Group 1: Dexlansoprazole 30 mg Group 2: Dexlansoprazole 60 mg
Hide Arm/Group Description Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1. Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Group 1: Dexlansoprazole 30 mg Group 2: Dexlansoprazole 60 mg Total
Hide Arm/Group Description Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1. Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
29.4  (6.73) 29.4  (5.66) 29.4  (6.14)
[1]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
12
  60.0%
7
  35.0%
19
  47.5%
Male
8
  40.0%
13
  65.0%
21
  52.5%
[1]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
China Number Analyzed 20 participants 20 participants 40 participants
20
 100.0%
20
 100.0%
40
 100.0%
[1]
Measure Analysis Population Description: The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 20 participants 20 participants 40 participants
165.88  (7.688) 167.38  (7.720) 166.63  (7.642)
[1]
Measure Analysis Population Description: The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 20 participants 20 participants 40 participants
61.22  (8.469) 62.43  (8.542) 61.82  (8.418)
[1]
Measure Analysis Population Description: 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)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 20 participants 20 participants 40 participants
22.17  (1.808) 22.22  (1.911) 22.20  (1.836)
[1]
Measure Analysis Population Description: The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
Smoking Classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Never smoked
15
  75.0%
17
  85.0%
32
  80.0%
Ex-Smoker
5
  25.0%
3
  15.0%
8
  20.0%
[1]
Measure Analysis Population Description: 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)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Had caffeine consumption
0
   0.0%
0
   0.0%
0
   0.0%
Had no caffeine consumption
20
 100.0%
20
 100.0%
40
 100.0%
[1]
Measure Analysis Population Description: 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)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Had alcohol consumption
0
   0.0%
0
   0.0%
0
   0.0%
Had no alcohol consumption
20
 100.0%
20
 100.0%
40
 100.0%
[1]
Measure Analysis Population Description: 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Had a history of drug abuse/addiction
0
   0.0%
0
   0.0%
0
   0.0%
Had no history of drug abuse/addiction
20
 100.0%
20
 100.0%
40
 100.0%
[1]
Measure Analysis Population Description: The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.
1.Primary Outcome
Title Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Dexlansoprazole 30 mg Group 2: Dexlansoprazole 60 mg
Hide Arm/Group Description:
Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
732
(43.73%)
1756
(45.83%)
2.Primary Outcome
Title AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Dexlansoprazole 30 mg Group 2: Dexlansoprazole 60 mg
Hide Arm/Group Description:
Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour*nanogram per milliliter (h*ng/mL)
3660
(61.38%)
10198
(61.09%)
3.Primary Outcome
Title AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Dexlansoprazole 30 mg Group 2: Dexlansoprazole 60 mg
Hide Arm/Group Description:
Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
Overall Number of Participants Analyzed 20 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
3701
(62.83%)
10340
(64.20%)
Time Frame Baseline up to 30 days after last dose (Day 31)
Adverse Event Reporting Description 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.
 
Arm/Group Title Group 1: Dexlansoprazole 30 mg Group 2: Dexlansoprazole 60 mg
Hide Arm/Group Description Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1. Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.
All-Cause Mortality
Group 1: Dexlansoprazole 30 mg Group 2: Dexlansoprazole 60 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
Group 1: Dexlansoprazole 30 mg Group 2: Dexlansoprazole 60 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1: Dexlansoprazole 30 mg Group 2: Dexlansoprazole 60 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   3/20 (15.00%)   1/20 (5.00%) 
Infections and infestations     
Upper respiratory tract infection  1  1/20 (5.00%)  1/20 (5.00%) 
Investigations     
Alanine aminotransferase increased  1  1/20 (5.00%)  0/20 (0.00%) 
Blood bilirubin increased  1  1/20 (5.00%)  0/20 (0.00%) 
White blood cells urine  1  1/20 (5.00%)  0/20 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03316976    
Other Study ID Numbers: TAK-390MR_106
U1111-1192-7711 ( Registry Identifier: WHO )
CTR20160792 ( Registry Identifier: SFDA )
First Submitted: October 18, 2017
First Posted: October 23, 2017
Results First Submitted: February 8, 2019
Results First Posted: May 10, 2019
Last Update Posted: May 10, 2019