Trial Outcomes & Findings for A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants (NCT NCT03173170)
NCT ID: NCT03173170
Last Updated: 2019-01-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
TAK-954 0.2 mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose; Itraconazole 200 mg and TAK-954 0.2 mg: Day 4 pre-dose and at multiple time points (up to 120 hours) post-dose
Results posted on
2019-01-15
Participant Flow
Participants took part in the study at 1 investigative site in United States from 31 May 2017 to 24 July 2017.
Healthy participants were enrolled in this single sequence 2-period crossover study to receive TAK-954 0.2 milligram (mg) in Intervention Period 1 followed by itraconazole 200 mg + TAK-954 0.2 mg in Intervention Period 2.
Participant milestones
| Measure |
TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period, followed by a minimum of 7-day washout period, further followed by itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period.
|
|---|---|
|
First Intervention Period (6 Days)
STARTED
|
10
|
|
First Intervention Period (6 Days)
COMPLETED
|
10
|
|
First Intervention Period (6 Days)
NOT COMPLETED
|
0
|
|
Washout Period (at Least 7 Days)
STARTED
|
10
|
|
Washout Period (at Least 7 Days)
COMPLETED
|
10
|
|
Washout Period (at Least 7 Days)
NOT COMPLETED
|
0
|
|
Intervention Period 2 (9 Days)
STARTED
|
10
|
|
Intervention Period 2 (9 Days)
COMPLETED
|
10
|
|
Intervention Period 2 (9 Days)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg
n=10 Participants
TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period, followed by a minimum of 7-day washout period, further followed by itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period.
|
|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 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
|
10 Participants
n=5 Participants
|
|
Weight
|
73.72 kilogram (kg)
STANDARD_DEVIATION 11.534 • n=5 Participants
|
|
Height
|
174.4 centimeter (cm)
STANDARD_DEVIATION 10.17 • n=5 Participants
|
|
Body mass index (BMI)
|
24.2 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.90 • n=5 Participants
|
PRIMARY outcome
Timeframe: TAK-954 0.2 mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose; Itraconazole 200 mg and TAK-954 0.2 mg: Day 4 pre-dose and at multiple time points (up to 120 hours) post-dosePopulation: The pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
TAK-954 0.2 mg
n=10 Participants
TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period.
|
Itraconazole 200 mg and TAK-954 0.2 mg
n=10 Participants
Itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period.
|
|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-954
|
2.642 nanogram/milliliter (ng/mL)
Standard Deviation 0.4426
|
2.840 nanogram/milliliter (ng/mL)
Standard Deviation 0.6497
|
PRIMARY outcome
Timeframe: TAK-954 0.2 mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose; Itraconazole 200 mg and TAK-954 0.2mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dosePopulation: The PK set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration. PK analysis set where Day 1 and 4 assessments were available.
Outcome measures
| Measure |
TAK-954 0.2 mg
n=10 Participants
TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period.
|
Itraconazole 200 mg and TAK-954 0.2 mg
n=10 Participants
Itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period.
|
|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954
|
28.59 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 6.550
|
43.15 hour*nanogram per milliliter (hr*ng/mL)
Standard Deviation 10.265
|
Adverse Events
TAK-954 0.2 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Itraconazole 200 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Itraconazole 200 mg and TAK-954 0.2 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-954 0.2 mg
n=10 participants at risk
TAK-954 0.2 mg, infusion, intravenously, once on Day 1 of First Intervention Period.
|
Itraconazole 200 mg
n=10 participants at risk
Itraconazole 200 mg, capsule, orally, once daily on Days 1 to 3 of Second Intervention Period.
|
Itraconazole 200 mg and TAK-954 0.2 mg
n=10 participants at risk
Itraconazole 200 mg, capsule, orally, once daily on Days 4 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Anal incontinence
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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
|
30.0%
3/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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.
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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
Presyncope
|
10.0%
1/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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%
0/10 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to Day 9 of Second Intervention Period
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