Trial Outcomes & Findings for A Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants (NCT NCT03849690)
NCT ID: NCT03849690
Last Updated: 2021-06-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
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
Results posted on
2021-06-15
Participant Flow
Participants took part in the study at 1 investigative site in the Unites states from 27 February 2019 to 15 April 2019.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Period 1 (3 Days)
STARTED
|
12
|
|
Period 1 (3 Days)
COMPLETED
|
12
|
|
Period 1 (3 Days)
NOT COMPLETED
|
0
|
|
Washout Period (at Least 4 Days)
STARTED
|
12
|
|
Washout Period (at Least 4 Days)
COMPLETED
|
12
|
|
Washout Period (at Least 4 Days)
NOT COMPLETED
|
0
|
|
Period 2 (6 Days)
STARTED
|
12
|
|
Period 2 (6 Days)
COMPLETED
|
12
|
|
Period 2 (6 Days)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial to Evaluate the Effect of the Proton Pump Inhibitor Esomeprazole on the Single-dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
TAK-906 25 mg + Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 9.73 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
|
Weight
|
72.30 kilogram (kg)
STANDARD_DEVIATION 11.532 • n=99 Participants
|
|
Height
|
168.5 centimeter (cm)
STANDARD_DEVIATION 8.48 • n=99 Participants
|
|
Body Mass Index (BMI)
|
25.315 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.4635 • n=99 Participants
|
PRIMARY outcome
Timeframe: 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 dosePopulation: 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).
Outcome measures
| Measure |
TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
Esomeprazole 40 mg and TAK-906 25 mg
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.
|
|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-906
|
19.76 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36.5
|
17.24 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 40.5
|
—
|
PRIMARY outcome
Timeframe: 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 dosePopulation: 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).
Outcome measures
| Measure |
TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
Esomeprazole 40 mg and TAK-906 25 mg
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.
|
|---|---|---|---|
|
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
|
37.98 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 31.2
|
—
|
PRIMARY outcome
Timeframe: 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 dosePopulation: 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).
Outcome measures
| Measure |
TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
Esomeprazole 40 mg and TAK-906 25 mg
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.
|
|---|---|---|---|
|
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
|
38.85 ng*h/mL
Geometric Coefficient of Variation 31.1
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
|---|---|---|---|
|
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
|
1 Participants
|
3 Participants
|
|
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
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
TAK-906 25 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Esomeprazole 40 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Esomeprazole 40 mg and TAK-906 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-906 25 mg
n=12 participants at risk
TAK-906 25 mg, capsule, orally, once on Day 1 of Study Period 1.
|
Esomeprazole 40 mg
n=12 participants at risk
Esomeprazole 40 mg, capsule, orally, once daily on Days 1 to 5 of Study Period 2.
|
Esomeprazole 40 mg and TAK-906 25 mg
n=12 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Influenza like illness
|
0.00%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
8.3%
1/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
8.3%
1/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
|
General disorders
Vessel puncture site reaction
|
0.00%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
8.3%
1/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
8.3%
1/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
8.3%
1/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
8.3%
1/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
8.3%
1/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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%
0/12 • TEAEs are AEs that started after the first dose of study drug and no more than 14 days after the last dose of study drug in Study Period 2 (Day 23)
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