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

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03316976
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 15.6

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the pharmacokinetics after a single dose of dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Dexlansoprazole	Phase 1

Detailed Description

The drug being tested in this study is called Dexlansoprazole. This study will assess the pharmacokinetics, safety and tolerability of a single oral dose of Dexlansoprazole 30 mg and 60 mg delayed-release capsules in healthy participants.

The study will enroll approximately 40 participants, 20 participants in each parallel arm. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

• Group 1: A single oral dose of Dexlansoprazole 30 mg delayed-release capsule

• Group 2: A single oral dose of Dexlansoprazole 60 mg delayed-release capsule

All participants will be asked to take single dose of study drug on Day 1.

This single center trial will be conducted in China. The overall time to participate in this study is approximately 40 days. Participants will be contacted by telephone or will make a final visit to the clinic 5 to 10 days after receiving their last dose of study drug for a follow-up assessment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Single-Center, Open-Label, 2-Arm Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 mg and 60 mg Delayed-Release Capsules in Healthy Chinese Subjects
• Actual Study Start Date: Nov 22, 2017
• Actual Primary Completion Date: Feb 8, 2018
• Actual Study Completion Date: Feb 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Dexlansoprazole 30 mg Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1.	Drug: Dexlansoprazole; Dexlansoprazole delayed-release capsule.; Other Names: TAK-390 Modified Release (TAK-390MR) dexlansoprazole
Experimental: Group 2: Dexlansoprazole 60 mg Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1.	Drug: Dexlansoprazole; Dexlansoprazole delayed-release capsule.; Other Names: TAK-390 Modified Release (TAK-390MR) dexlansoprazole

Outcome Measures

Primary Outcome Measures

1. Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole [Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose]

2. AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole [Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose]

3. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole [Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Is a healthy adult man or woman of Chinese descent.

2. Is aged 18 to 45 years, inclusive, at the time of informed consent and study medication dose.

3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 19.0 to 26.0 kilogram per square meter (kg/m^2), inclusive at Screening Visit.

Exclusion Criteria:

1. Has a known hypersensitivity to any component of the formulation of dexlansoprazole or other drug with the same mechanism of action (including lansoprazole, omeprazole, esomeprazole, rabeprazole, ilaprazole, or pantoprazole), or related compounds.

2. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol for 48 hours prior to Check-in (Day -1) throughout the confinement and for 48 hours prior to each clinic visit and drugs throughout the study.

3. Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in (Day -1) or is unwilling to abstain from these products for the duration of the study.

4. Has poor peripheral venous access.

5. Has donated blood products (such as plasma), whole blood or had a significant blood loss (450 millimeter [mL]) within 56 days of Day 1.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phase I Clinical Trial Department	Beijing	Beijing	China	100005

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Medical Director, Takeda

Study Documents (Full-Text)

• Statistical Analysis Plan - Mar 22, 2018
• Study Protocol - Nov 28, 2017

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT03316976
• Other Study ID Numbers: TAK-390MR_106; U1111-1192-7711; CTR20160792
• First Posted: Oct 23, 2017
• Last Update Posted: May 10, 2019
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Takeda: Drug therapy
• Additional relevant MeSH terms: Dexlansoprazole; Lansoprazole

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 1 investigative site in China from 22 November 2017 to 08 February 2018.
Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Group 1: Dexlansoprazole 30 mg	Group 2: Dexlansoprazole 60 mg	Total
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 Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.4 (6.73)	29.4 (5.66)	29.4 (6.14)
Sex: Female, Male (Count of Participants)
Female	12 60%	7 35%	19 47.5%
Male	8 40%	13 65%	21 52.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
China	20 100%	20 100%	40 100%
Height (centimeter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeter]	165.88 (7.688)	167.38 (7.720)	166.63 (7.642)
Weight (kilogram) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram]	61.22 (8.469)	62.43 (8.542)	61.82 (8.418)
Body Mass Index (BMI) (kilogram per square meter (kg/m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram per square meter (kg/m^2)]	22.17 (1.808)	22.22 (1.911)	22.20 (1.836)
Smoking Classification (Count of Participants)
Never smoked	15 75%	17 85%	32 80%
Ex-Smoker	5 25%	3 15%	8 20%
Caffeine Consumption Status 72 hours Prior to Check-in (Day -1) (Count of Participants)
Had caffeine consumption	0 0%	0 0%	0 0%
Had no caffeine consumption	20 100%	20 100%	40 100%
Alcohol Consumption Status 7 Days Prior to Check-in (Day -1) (Count of Participants)
Had alcohol consumption	0 0%	0 0%	0 0%
Had no alcohol consumption	20 100%	20 100%	40 100%
Drug Abuse/Addiction (Count of Participants)
Had a history of drug abuse/addiction	0 0%	0 0%	0 0%
Had no history of drug abuse/addiction	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
Time Frame	Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Outcome Measure Data

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
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.
Measure Participants	20	20
Geometric Mean (Geometric Coefficient of Variation) [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
Time Frame	Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Outcome Measure Data

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
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.
Measure Participants	20	20
Geometric Mean (Geometric Coefficient of Variation) [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
Time Frame	Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Outcome Measure Data

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
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.
Measure Participants	20	20
Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL]	3701 (62.83)	10340 (64.20)

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Group 1: Dexlansoprazole 30 mg		Group 2: Dexlansoprazole 60 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: Dexlansoprazole 30 mg		Group 2: Dexlansoprazole 60 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/20 (15%)		1/20 (5%)
Infections and infestations
Upper respiratory tract infection	1/20 (5%)		1/20 (5%)
Investigations
Alanine aminotransferase increased	1/20 (5%)		0/20 (0%)
Blood bilirubin increased	1/20 (5%)		0/20 (0%)
White blood cells urine	1/20 (5%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.