Trial Outcomes & Findings for A Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of Organic Anion Transporting Polypeptide (OATP) 1B1 and OATP1B3 on the Single-Dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants (NCT NCT04121078)
NCT ID: NCT04121078
Last Updated: 2020-12-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 1: time zero and at multiple time points (up to 48 hours) post dose
Results posted on
2020-12-09
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 15 October 2019 to 16 November 2019.
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Study Period 1 (1 Day)
STARTED
|
6
|
6
|
|
Study Period 1 (1 Day)
COMPLETED
|
6
|
6
|
|
Study Period 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (at Least 7 Days)
STARTED
|
6
|
6
|
|
Washout Period (at Least 7 Days)
COMPLETED
|
6
|
6
|
|
Washout Period (at Least 7 Days)
NOT COMPLETED
|
0
|
0
|
|
Study Period 2 (1 Day)
STARTED
|
6
|
6
|
|
Study Period 2 (1 Day)
COMPLETED
|
6
|
6
|
|
Study Period 2 (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of Organic Anion Transporting Polypeptide (OATP) 1B1 and OATP1B3 on the Single-Dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Sequence AB: TAK-906 25 mg + TAK-906 25 mg and Rifampin 600 mg
n=6 Participants
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.
|
Sequence BA: TAK-906 25 mg and Rifampin 600 mg + TAK-906 25 mg
n=6 Participants
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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 13.47 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 8.12 • n=7 Participants
|
37.3 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American, White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Weight
|
74.73 kilogram (kg)
STANDARD_DEVIATION 9.943 • n=5 Participants
|
84.25 kilogram (kg)
STANDARD_DEVIATION 13.581 • n=7 Participants
|
79.49 kilogram (kg)
STANDARD_DEVIATION 12.389 • n=5 Participants
|
|
Height
|
172.3 centimeter (cm)
STANDARD_DEVIATION 11.74 • n=5 Participants
|
177.0 centimeter (cm)
STANDARD_DEVIATION 9.38 • n=7 Participants
|
174.7 centimeter (cm)
STANDARD_DEVIATION 10.42 • n=5 Participants
|
|
Body Mass Index (BMI)
|
25.168 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 2.3720 • n=5 Participants
|
26.770 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 1.8285 • n=7 Participants
|
25.969 kilogram per square meter (kg/m˄2)
STANDARD_DEVIATION 2.1856 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: time zero and at multiple time points (up to 48 hours) post dosePopulation: The pharmacokinetic (PK) set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Treatment A: TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of either Study Period 1 or 2.
|
Treatment B: Rifampin 600 mg and TAK-906 25 mg
n=12 Participants
Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg, capsule, orally, once immediately after the end of infusion on Day 1 of either Study Period 1 or 2.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-906
|
14.37 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38.7
|
89.62 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 68.6
|
PRIMARY outcome
Timeframe: Day 1: time zero and at multiple time points (up to 48 hours) post dosePopulation: The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Treatment A: TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of either Study Period 1 or 2.
|
Treatment B: Rifampin 600 mg and TAK-906 25 mg
n=12 Participants
Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg, capsule, orally, once immediately after the end of infusion on Day 1 of either Study Period 1 or 2.
|
|---|---|---|
|
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
|
168.5 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 49.9
|
PRIMARY outcome
Timeframe: Day 1: time zero and at multiple time points (up to 48 hours) post dosePopulation: The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Treatment A: TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of either Study Period 1 or 2.
|
Treatment B: Rifampin 600 mg and TAK-906 25 mg
n=12 Participants
Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg, capsule, orally, once immediately after the end of infusion on Day 1 of either Study Period 1 or 2.
|
|---|---|---|
|
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
|
168.3 ng*hr/mL
Geometric Coefficient of Variation 49.9
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment A: TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of either Study Period 1 or 2.
|
Treatment B: Rifampin 600 mg and TAK-906 25 mg
n=12 Participants
Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg, capsule, orally, once immediately after the end of infusion on Day 1 of either Study Period 1 or 2.
|
|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment A: TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of either Study Period 1 or 2.
|
Treatment B: Rifampin 600 mg and TAK-906 25 mg
n=12 Participants
Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg, capsule, orally, once immediately after the end of infusion on Day 1 of either Study Period 1 or 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment A: TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of either Study Period 1 or 2.
|
Treatment B: Rifampin 600 mg and TAK-906 25 mg
n=12 Participants
Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg, capsule, orally, once immediately after the end of infusion on Day 1 of either Study Period 1 or 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment A: TAK-906 25 mg
n=12 Participants
TAK-906 25 mg, capsule, orally, once on Day 1 of either Study Period 1 or 2.
|
Treatment B: Rifampin 600 mg and TAK-906 25 mg
n=12 Participants
Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg, capsule, orally, once immediately after the end of infusion on Day 1 of either Study Period 1 or 2.
|
|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
|
0 Participants
|
0 Participants
|
Adverse Events
Treatment A: TAK-906 25 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treatment B: Rifampin 600 mg and TAK-906 25 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A: TAK-906 25 mg
n=12 participants at risk
TAK-906 25 mg, capsule, orally, once on Day 1 of either Study Period 1 or 2.
|
Treatment B: Rifampin 600 mg and TAK-906 25 mg
n=12 participants at risk
Rifampin 600 mg, infusion, intravenously along with TAK-906 25 mg, capsule, orally, once immediately after the end of infusion on Day 1 of either Study Period 1 or 2.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • TEAEs are adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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 adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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
|
16.7%
2/12 • TEAEs are adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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 adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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
Sensory disturbance
|
8.3%
1/12 • TEAEs are adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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 adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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
Cough
|
0.00%
0/12 • TEAEs are adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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 adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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
Nasal congestion
|
0.00%
0/12 • TEAEs are adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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 adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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
Sinus congestion
|
8.3%
1/12 • TEAEs are adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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 adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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
Sneezing
|
8.3%
1/12 • TEAEs are adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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 adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.3%
1/12 • TEAEs are adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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 adverse events (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 (up to Day 23)
At each visit the investigator had to document any occurrence of AEs 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