Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to evaluate the effect of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of orally administered TAK-906.
Detailed description
The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants to evaluate the effect of a PPI esomeprazole on the PK of TAK-906. The study will enroll approximately 12 participants. Participants will be assigned to the following treatment sequence: • TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg All participants will be given an oral dose of TAK-906 and Esomeprazole. This single center trial will be conducted in the United States. The overall duration to participate in this study is 52 days. Participants will make visit to the clinic during Period 1 and Period 2 in addition to approximately 10 to 14 days after receiving their last dose of TAK-906 for a follow up assessment.
Interventions
DRUGTAK-906
TAK-906 capsules.
DRUGEsomeprazole
Esomeprazole capsules.
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Continuous non-smoker who has not used nicotine containing products for at least 3 months prior to the first dosing and throughout the study, based on screening urine cotinine test. 2. Has a body mass index (BMI) greater than or equal to (\>=) 18 and less than or equal to (\<=) 30 kilogram per square meter (kg/m\^2) at Screening.
Exclusion criteria
1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing. 2. QT interval corrected using Fridericia's formula (QTcF) interval is greater than (\>) 450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance by the Investigator or designee at screening. 3. Donation of blood or significant blood loss (example, approximately 500 milliliter \[mL\]) within 56 days prior to the first dosing. 4. Plasma donation within 7 days prior to the first dosing. 5. Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30 day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Study Period 1 of the current study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-906 | TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 | TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 | TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) | A severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 scales as severe(severe or medically significant but not immediately life threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 scales as life-threatening consequences, urgent intervention indicated, and Grade 5 scales as death related to AE. |
| Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values | Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) | — |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) | — |
| Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) | Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23) | — |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in the Unites states from 27 February 2019 to 15 April 2019.
Pre-assignment details
Healthy participants were enrolled in this single sequence, 2-period cross-over design study to receive TAK-906 25 milligram (mg) in Study Period 1 followed by esomeprazole 40 mg and TAK-906 25 mg in Study Period 2.
Participants by arm
| Arm | Count |
|---|---|
| TAK-906 25 mg + Esomeprazole 40 mg and TAK-906 25 mg TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 4 days, further followed by esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 along with TAK-906 25 mg, capsule, orally, once on Day 4 of Study Period 2. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | TAK-906 25 mg + Esomeprazole 40 mg and TAK-906 25 mg |
|---|---|
| Age, Continuous | 37.8 years STANDARD_DEVIATION 9.73 |
| Body Mass Index (BMI) | 25.315 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.4635 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 168.5 centimeter (cm) STANDARD_DEVIATION 8.48 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
| Weight | 72.30 kilogram (kg) STANDARD_DEVIATION 11.532 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 2 / 12 | 1 / 12 | 3 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906
Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose
Population: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 25 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 | 44.03 ng*h/mL | Geometric Coefficient of Variation 27.5 |
| Esomeprazole 40 mg and TAK-906 25 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 | 38.85 ng*h/mL | Geometric Coefficient of Variation 31.1 |
p-value: 0.301190% CI: [0.78, 1]ANOVA
Primary
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906
Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose
Population: The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 25 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 | 43.31 nanogram*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 27.8 |
| Esomeprazole 40 mg and TAK-906 25 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 | 37.98 nanogram*hour per milliliter (ng*h/mL) | Geometric Coefficient of Variation 31.2 |
p-value: 0.086590% CI: [0.77, 0.99]ANOVA
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-906
Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose
Population: The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations).
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| TAK-906 25 mg | Cmax: Maximum Observed Plasma Concentration for TAK-906 | 19.76 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 36.5 |
| Esomeprazole 40 mg and TAK-906 25 mg | Cmax: Maximum Observed Plasma Concentration for TAK-906 | 17.24 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 40.5 |
p-value: 0.301190% CI: [0.7, 1.09]ANOVA
Secondary
Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs
A severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 scales as severe(severe or medically significant but not immediately life threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 scales as life-threatening consequences, urgent intervention indicated, and Grade 5 scales as death related to AE.
Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Population: The safety set included all participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TAK-906 25 mg | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | SAEs | 0 Participants |
| TAK-906 25 mg | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | TEAEs | 2 Participants |
| TAK-906 25 mg | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | Grade 3 or Higher TEAEs | 0 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | SAEs | 0 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | TEAEs | 1 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | Grade 3 or Higher TEAEs | 0 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | TEAEs | 3 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | Grade 3 or Higher TEAEs | 0 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs | SAEs | 0 Participants |
Secondary
Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values
Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Population: The safety set included all participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values | 0 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values | 0 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG)
Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Population: The safety set included all participants who received at least one dose of study drug. The safety set where data at specified time points was available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) | 0 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) | 0 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) | 0 Participants |
Secondary
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Population: The safety set included all participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |
| Esomeprazole 40 mg and TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | 0 Participants |