Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to evaluate the effect of single dose intravenous rifampin 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 to evaluate the effect of single dose intravenous rifampin on the single-dose PK of oral TAK-906 in healthy adult participants. The study will enroll approximately 12 participants. Participants will be randomly assigned to one of the two treatment sequences AB or BA: * Sequence AB: TAK-906 25 mg, followed by a washout period of at least 7 days, then Rifampin 600 mg and TAK-906 25 mg * Sequence BA: Rifampin 600 mg and TAK-906 25 mg, followed by a washout period of at least 7 days, then TAK-906 25 mg This single center trial will be conducted in the United States. The overall time to participate in this study is 49 Days. All participants will make final visit 14 days after receiving their last dose of study drug for follow up assessment.
Interventions
DRUGTAK-906
TAK-906 capsule.
DRUGRifampin
Rifampin infusion.
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 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. Body Mass Index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 30.0 kilogram per square meter (kg/ m\^2) at screening. 3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs, as deemed by the investigator or designee.
Exclusion criteria
1. Positive urine drug or alcohol results at screening and each check in. 2. Positive urine cotinine at screening. 3. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV). 4. QT interval with Fridericia's correction (QTcF) interval is \>450 millisecond (msec) or ECG findings are deemed abnormal with clinical significance by the investigator or designee at screening. 5. Estimated creatinine clearance \<90 milliliter per minute (mL/min) at screening. 6. Has been on a diet incompatible with the on-study diet, in the opinion of the investigator or designee, within the 30 days prior to the first dosing and throughout the study. 7. Donation of blood or significant blood loss (example, approximately 500 milliliter \[mL\]) within 56 days prior to the first dosing. 8. Plasma donation within 7 days prior to the first dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-906 | Day 1: time zero and at multiple time points (up to 48 hours) post dose |
| AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 | Day 1: time zero and at multiple time points (up to 48 hours) post dose |
| AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906 | Day 1: time zero and at multiple time points (up to 48 hours) post dose |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) |
| Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values | Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) |
| Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values | Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) |
| Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings | Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23) |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in the United States from 15 October 2019 to 16 November 2019.
Pre-assignment details
Healthy participants were enrolled in 1 of the 2 treatment sequences of this 2-period crossover study to receive TAK-906 25 milligram (mg) alone (Treatment A) and TAK-906 25 mg along with rifampin 600 mg (Treatment B).
Participants by arm
| Arm | Count |
|---|---|
| Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 2. | 6 |
| Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg (Treatment B), capsule, orally, once immediately after the end of infusion on Day 1 of Study Period 1, followed by a washout period of at least 7 days, further followed by TAK-906 25 mg (Treatment A), capsule, orally, once on Day 1 of Study Period 2. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg | Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg | Total |
|---|---|---|---|
| Age, Continuous | 36.7 years STANDARD_DEVIATION 13.47 | 38.0 years STANDARD_DEVIATION 8.12 | 37.3 years STANDARD_DEVIATION 10.63 |
| Body Mass Index (BMI) | 25.168 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 2.372 | 26.770 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 1.8285 | 25.969 kilogram per square meter (kg/m˄2) STANDARD_DEVIATION 2.1856 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 172.3 centimeter (cm) STANDARD_DEVIATION 11.74 | 177.0 centimeter (cm) STANDARD_DEVIATION 9.38 | 174.7 centimeter (cm) STANDARD_DEVIATION 10.42 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American, White | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 6 Participants | 9 Participants |
| Region of Enrollment United States | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
| Weight | 74.73 kilogram (kg) STANDARD_DEVIATION 9.943 | 84.25 kilogram (kg) STANDARD_DEVIATION 13.581 | 79.49 kilogram (kg) STANDARD_DEVIATION 12.389 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 6 / 12 | 2 / 12 |
| serious Total, serious adverse events | 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: Day 1: time zero and at multiple time points (up to 48 hours) post dose
Population: The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: TAK-906 25 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 | 32.68 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 23.9 |
| Treatment B: Rifampin 600 mg and TAK-906 25 mg | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 | 168.5 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 49.9 |
90% CI: [4.25, 6.25]
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: Day 1: time zero and at multiple time points (up to 48 hours) post dose
Population: The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: 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 | 32.32 ng*hr/mL | Geometric Coefficient of Variation 23.8 |
| Treatment B: Rifampin 600 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 | 168.3 ng*hr/mL | Geometric Coefficient of Variation 49.9 |
90% CI: [4.29, 6.32]
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-906
Time frame: Day 1: time zero and at multiple time points (up to 48 hours) post dose
Population: The pharmacokinetic (PK) set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: TAK-906 25 mg | Cmax: Maximum Observed Plasma Concentration for TAK-906 | 14.37 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 38.7 |
| Treatment B: Rifampin 600 mg and TAK-906 25 mg | Cmax: Maximum Observed Plasma Concentration for TAK-906 | 89.62 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 68.6 |
90% CI: [4.62, 8.42]
Secondary
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)
Population: The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A: TAK-906 25 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 6 Participants |
| Treatment B: Rifampin 600 mg and TAK-906 25 mg | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | 2 Participants |
Secondary
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
Time frame: Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)
Population: The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A: TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings | 0 Participants |
| Treatment B: Rifampin 600 mg and TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings | 0 Participants |
Secondary
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
Time frame: Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)
Population: The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A: TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values | 0 Participants |
| Treatment B: Rifampin 600 mg and TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values | 0 Participants |
Secondary
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Time frame: Baseline up to 14 days after the last dose of study drug in Study Period 2 (up to Day 23)
Population: The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A: TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values | 0 Participants |
| Treatment B: Rifampin 600 mg and TAK-906 25 mg | Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values | 0 Participants |