Trial Outcomes & Findings for A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants (NCT NCT02906813)
NCT ID: NCT02906813
Last Updated: 2018-09-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Results posted on
2018-09-19
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 12 September 2016 to 09 November 2016.
Healthy participants were enrolled in 1 of the 3 treatment sequences that determined the order of the three treatments received: TAK-935 300 milligram (mg) tablets in fasted state, TAK-935 300 mg tablets in fed state and TAK-935 300 mg solution in fasted state.
Participant milestones
| Measure |
TAK-935 300 mg: Tablets Fed + Tablets Fasted + Solution Fasted
TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3.
|
TAK-935 300 mg: Tablets Fasted + Solution Fasted + Tablets Fed
TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 3.
|
TAK 935 300 mg: Solution Fasted + Tablets Fed + Tablets Fasted
TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3.
|
|---|---|---|---|
|
Intervention Period 1 (3 Days)
STARTED
|
3
|
3
|
3
|
|
Intervention Period 1 (3 Days)
COMPLETED
|
3
|
3
|
3
|
|
Intervention Period 1 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period 1 (at Least 3 Days)
STARTED
|
3
|
3
|
3
|
|
Washout Period 1 (at Least 3 Days)
COMPLETED
|
3
|
3
|
3
|
|
Washout Period 1 (at Least 3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Intervention Period 2 (3 Days)
STARTED
|
3
|
3
|
3
|
|
Intervention Period 2 (3 Days)
COMPLETED
|
3
|
3
|
3
|
|
Intervention Period 2 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period 2 (at Least 3 Days)
STARTED
|
3
|
3
|
3
|
|
Washout Period 2 (at Least 3 Days)
COMPLETED
|
3
|
3
|
3
|
|
Washout Period 2 (at Least 3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Intervention Period 3 (3 Days)
STARTED
|
3
|
3
|
3
|
|
Intervention Period 3 (3 Days)
COMPLETED
|
3
|
3
|
3
|
|
Intervention Period 3 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants
Baseline characteristics by cohort
| Measure |
TAK-935 300 mg: Tablets Fasted + Solution Fasted + Tablets Fed
n=3 Participants
TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 3.
|
TAK 935 300 mg: Solution Fasted + Tablets Fed + Tablets Fasted
n=3 Participants
TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3.
|
Total
n=9 Participants
Total of all reporting groups
|
TAK-935 300 mg: Tablets Fed + Tablets Fasted + Solution Fasted
n=3 Participants
TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of Intervention Period 1, followed by a minimum 3-day washout period, further followed by TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of Intervention Period 2, followed by a minimum 3-day washout period, further followed by TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of Intervention Period 3.
|
|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 3.00 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 13.58 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 8.00 • n=4 Participants
|
37.3 years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
|
Height
|
171.0 centimeter (cm)
STANDARD_DEVIATION 2.00 • n=7 Participants
|
170.3 centimeter (cm)
STANDARD_DEVIATION 1.53 • n=5 Participants
|
171.1 centimeter (cm)
STANDARD_DEVIATION 3.44 • n=4 Participants
|
172.0 centimeter (cm)
STANDARD_DEVIATION 6.24 • n=5 Participants
|
|
Weight
|
78.20 kilogram (kg)
STANDARD_DEVIATION 1.311 • n=7 Participants
|
71.50 kilogram (kg)
STANDARD_DEVIATION 10.096 • n=5 Participants
|
77.62 kilogram (kg)
STANDARD_DEVIATION 9.039 • n=4 Participants
|
83.17 kilogram (kg)
STANDARD_DEVIATION 10.970 • n=5 Participants
|
|
Body Mass Index (BMI)
|
26.75 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 0.889 • n=7 Participants
|
24.62 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.295 • n=5 Participants
|
26.46 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.430 • n=4 Participants
|
28.01 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 1.784 • n=5 Participants
|
|
Smoking Classification
Never smoked
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
|
Smoking Classification
Ex-smoker
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
|
No Alcohol Consumption
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
|
No Xanthine/Caffeine Consumption
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
|
Female Reproductive Status
Postmenopausal
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
|
Female Reproductive Status
Having childbearing potential
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
|
Female Reproductive Status
Not applicable
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The pharmacokinetic (PK) set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its metabolite (M-I).
Outcome measures
| Measure |
TAK-935 300 mg Tablets Fed
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Tablets Fasted
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Solution Fasted
n=9 Participants
TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-935
|
477.000 nanogram per milliliter (ng/mL)
Standard Deviation 298.0705
|
1150.889 nanogram per milliliter (ng/mL)
Standard Deviation 710.5940
|
1882.000 nanogram per milliliter (ng/mL)
Standard Deviation 1250.7022
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The PK set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its M-I.
Outcome measures
| Measure |
TAK-935 300 mg Tablets Fed
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Tablets Fasted
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Solution Fasted
n=9 Participants
TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
|---|---|---|---|
|
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935
|
1170.954 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 386.1425
|
1328.482 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 496.8168
|
1601.806 nanogram hours per milliliter (ng*hr/mL)
Standard Deviation 711.7143
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dosePopulation: The PK analysis set where data on Day 1 was available. The PK set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its M-I.
Outcome measures
| Measure |
TAK-935 300 mg Tablets Fed
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Tablets Fasted
n=8 Participants
TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Solution Fasted
n=8 Participants
TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935
|
1182.641 ng*hr/mL
Standard Deviation 385.6485
|
1369.963 ng*hr/mL
Standard Deviation 523.2334
|
1564.307 ng*hr/mL
Standard Deviation 743.3798
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dose of study drug (Day 39)Population: The safety analysis set included all participants who were enrolled and received study drug.
Outcome measures
| Measure |
TAK-935 300 mg Tablets Fed
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Tablets Fasted
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Solution Fasted
n=9 Participants
TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
|---|---|---|---|
|
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
0 percentage of participants
|
22.2 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 11Population: The safety analysis set included all participants who were enrolled and received study drug.
Outcome measures
| Measure |
TAK-935 300 mg Tablets Fed
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Tablets Fasted
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Solution Fasted
n=9 Participants
TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 11Population: The safety analysis set included all participants who were enrolled and received study drug.
Outcome measures
| Measure |
TAK-935 300 mg Tablets Fed
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Tablets Fasted
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Solution Fasted
n=9 Participants
TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose.
|
22.2 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 11Population: The safety analysis set included all participants who were enrolled and received study drug.
Outcome measures
| Measure |
TAK-935 300 mg Tablets Fed
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Tablets Fasted
n=9 Participants
TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Solution Fasted
n=9 Participants
TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
|---|---|---|---|
|
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
|
33.3 percentage of participants
|
33.3 percentage of participants
|
55.6 percentage of participants
|
Adverse Events
TAK-935 300 mg Tablets Fed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TAK-935 300 mg Tablets Fasted
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TAK-935 300 mg Solution Fasted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TAK-935 300 mg Tablets Fed
n=9 participants at risk
TAK-935 3\*100 mg, tablets, orally, 30 minutes after starting ingestion of a high-fat meal, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Tablets Fasted
n=9 participants at risk
TAK-935 3\*100 mg, tablets, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
TAK-935 300 mg Solution Fasted
n=9 participants at risk
TAK-935 300 mg, solution, orally, after a 10-hour fast, once on Day 1 of either Intervention Period 1, 2 or 3.
|
|---|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug
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
Dermatitis contact
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug
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
|
0.00%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug
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.
|
11.1%
1/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug
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%
0/9 • Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days (Day 39) after the last dose of study drug
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