Healthy Volunteers
Conditions
Keywords
Drug therapy
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.
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.
Interventions
DRUGDexlansoprazole
Dexlansoprazole delayed-release capsule.
Sponsors
Takeda
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole | Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose |
| 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 |
| 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 |
Countries
China
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 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.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Dexlansoprazole 30 mg Dexlansoprazole 30 mg, delayed-release, capsule, orally, administered as single dose on Day 1. | 20 |
| Group 2: Dexlansoprazole 60 mg Dexlansoprazole 60 mg, delayed-release, capsule, orally, administered as single dose on Day 1. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Total | Group 2: Dexlansoprazole 60 mg | Group 1: Dexlansoprazole 30 mg |
|---|---|---|---|
| Age, Continuous | 29.4 years STANDARD_DEVIATION 6.14 | 29.4 years STANDARD_DEVIATION 5.66 | 29.4 years STANDARD_DEVIATION 6.73 |
| Alcohol Consumption Status 7 Days Prior to Check-in (Day -1) Had alcohol consumption | 0 Participants | 0 Participants | 0 Participants |
| Alcohol Consumption Status 7 Days Prior to Check-in (Day -1) Had no alcohol consumption | 40 Participants | 20 Participants | 20 Participants |
| Body Mass Index (BMI) | 22.20 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.836 | 22.22 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.911 | 22.17 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.808 |
| Caffeine Consumption Status 72 hours Prior to Check-in (Day -1) Had caffeine consumption | 0 Participants | 0 Participants | 0 Participants |
| Caffeine Consumption Status 72 hours Prior to Check-in (Day -1) Had no caffeine consumption | 40 Participants | 20 Participants | 20 Participants |
| Drug Abuse/Addiction Had a history of drug abuse/addiction | 0 Participants | 0 Participants | 0 Participants |
| Drug Abuse/Addiction Had no history of drug abuse/addiction | 40 Participants | 20 Participants | 20 Participants |
| Height | 166.63 centimeter STANDARD_DEVIATION 7.642 | 167.38 centimeter STANDARD_DEVIATION 7.72 | 165.88 centimeter STANDARD_DEVIATION 7.688 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment China | 40 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Female | 19 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 21 Participants | 13 Participants | 8 Participants |
| Smoking Classification Ex-Smoker | 8 Participants | 3 Participants | 5 Participants |
| Smoking Classification Never smoked | 32 Participants | 17 Participants | 15 Participants |
| Weight | 61.82 kilogram STANDARD_DEVIATION 8.418 | 62.43 kilogram STANDARD_DEVIATION 8.542 | 61.22 kilogram STANDARD_DEVIATION 8.469 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 3 / 20 | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
Population: 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 | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Dexlansoprazole 30 mg | 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 |
| Group 2: Dexlansoprazole 60 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole | 10340 h*ng/mL | Geometric Coefficient of Variation 64.2 |
Primary
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
Population: 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 | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Dexlansoprazole 30 mg | 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 |
| Group 2: Dexlansoprazole 60 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole | 10198 hour*nanogram per milliliter (h*ng/mL) | Geometric Coefficient of Variation 61.09 |
Primary
Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
Time frame: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Population: 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 | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Dexlansoprazole 30 mg | Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole | 732 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 43.73 |
| Group 2: Dexlansoprazole 60 mg | Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole | 1756 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 45.83 |