Trial Outcomes & Findings for A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants (NCT NCT03161405)
NCT ID: NCT03161405
Last Updated: 2019-01-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dose
Results posted on
2019-01-11
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 05 June 2017 to 10 July 2017.
Healthy participants were enrolled in single sequence 2-period crossover study to receive TAK-906 maleate 25 milligram (mg) in First Intervention Period followed by Itraconazole 200 mg along with TAK-906 maleate 25 mg in Second Intervention Period.
Participant milestones
| Measure |
TAK-906 Maleate 25mg;Itraconazole 200mg + TAK-906 Maleate 25mg
TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period, followed by a minimum of 4-day washout period, further followed by Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
|
|---|---|
|
First Intervention Period (3 Days)
STARTED
|
12
|
|
First Intervention Period (3 Days)
COMPLETED
|
12
|
|
First Intervention Period (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
|
|
Second Intervention Period (6 Days)
STARTED
|
12
|
|
Second Intervention Period (6 Days)
COMPLETED
|
11
|
|
Second Intervention Period (6 Days)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
TAK-906 Maleate 25mg;Itraconazole 200mg + TAK-906 Maleate 25mg
TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period, followed by a minimum of 4-day washout period, further followed by Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
|
|---|---|
|
Second Intervention Period (6 Days)
Positive urine drug screen
|
1
|
Baseline Characteristics
A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants
Baseline characteristics by cohort
| Measure |
TAK-906 Maleate 25mg;Itraconazole 200mg + TAK-906 Maleate 25mg
n=12 Participants
TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period, followed by a minimum of 4-day washout period, further followed by Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
|
|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 7.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
|
Weight
|
85.4 kilogram (kg)
STANDARD_DEVIATION 10.59 • n=5 Participants
|
|
Height
|
180.8 centimeter (cm)
STANDARD_DEVIATION 6.79 • n=5 Participants
|
|
Body Mass Index (BMI)
|
26.2 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.52 • n=5 Participants
|
PRIMARY outcome
Timeframe: TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dosePopulation: The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration.
Outcome measures
| Measure |
TAK-906 Maleate 25 mg
n=12 Participants
TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period.
|
Itraconazole 200 mg + TAK-906 Maleate 25 mg
n=11 Participants
Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-906
|
9.532 nanogram per milliliter (ng/mL)
Standard Deviation 4.6337
|
17.999 nanogram per milliliter (ng/mL)
Standard Deviation 4.8780
|
PRIMARY outcome
Timeframe: TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dosePopulation: The PK analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration.
Outcome measures
| Measure |
TAK-906 Maleate 25 mg
n=12 Participants
TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period.
|
Itraconazole 200 mg + TAK-906 Maleate 25 mg
n=11 Participants
Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
|
|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906
|
24.10 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 8.173
|
30.73 hour*nanogram per milliliter (h*ng/mL)
Standard Deviation 8.521
|
PRIMARY outcome
Timeframe: TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dosePopulation: The PK analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration. PK analysis set where Day 1 and 4 assessments were available.
Outcome measures
| Measure |
TAK-906 Maleate 25 mg
n=12 Participants
TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period.
|
Itraconazole 200 mg + TAK-906 Maleate 25 mg
n=11 Participants
Itraconazole 200 mg, solution, orally, once daily on Days 1 to 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
|
|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906
|
24.41 h*ng/mL
Standard Deviation 8.136
|
31.45 h*ng/mL
Standard Deviation 8.995
|
Adverse Events
TAK-906 Maleate 25 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Itraconazole 200 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Itraconazole 200 mg + TAK-906 Maleate 25 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-906 Maleate 25 mg
n=12 participants at risk
TAK-906 maleate 25 mg, capsule, orally, once on Day 1 of First Intervention Period.
|
Itraconazole 200 mg
n=11 participants at risk
Itraconazole 200 mg, solution, orally, once daily on Days 1 to 3 of Second Intervention Period.
|
Itraconazole 200 mg + TAK-906 Maleate 25 mg
n=11 participants at risk
Itraconazole 200 mg, solution, orally, once daily on Days 4 and 5 along with TAK-906 maleate 25 mg, capsule, orally on Day 4 of Second Intervention Period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose study drug up to 30 days after the last dose of study (approximately Day 36)
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose study drug up to 30 days after the last dose of study (approximately Day 36)
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.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose study drug up to 30 days after the last dose of study (approximately Day 36)
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.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/12 • Treatment-emergent adverse events are adverse events that started after the first dose study drug up to 30 days after the last dose of study (approximately Day 36)
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.
|
9.1%
1/11 • Treatment-emergent adverse events are adverse events that started after the first dose study drug up to 30 days after the last dose of study (approximately Day 36)
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%
0/11 • Treatment-emergent adverse events are adverse events that started after the first dose study drug up to 30 days after the last dose of study (approximately Day 36)
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