Trial Outcomes & Findings for A Study to Assess the Relative Bioavailability and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants (NCT NCT02480439)
NCT ID: NCT02480439
Last Updated: 2016-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period
Results posted on
2016-08-31
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 23 June 2015 to 02 September 2015.
Healthy participants were enrolled equally in 1 of 3 treatment sequences that determined the order of the three treatments received: TAK-648 0.3 mg tablet (fed), 0.3 mg tablet (fasted) and 0.3 mg solution (fasted).
Participant milestones
| Measure |
TAK-648 Sequence ABC
Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
|
TAK-648 Sequence BCA
Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
|
TAK-648 Sequence CAB
Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
|
|---|---|---|---|
|
Treatment Period 1
STARTED
|
8
|
8
|
8
|
|
Treatment Period 1
COMPLETED
|
8
|
8
|
8
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
8
|
7
|
8
|
|
Treatment Period 2
COMPLETED
|
8
|
7
|
8
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
8
|
7
|
7
|
|
Treatment Period 3
COMPLETED
|
8
|
7
|
7
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Relative Bioavailability and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants
Baseline characteristics by cohort
| Measure |
TAK-648 Sequence ABC
n=8 Participants
Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
|
TAK-648 Sequence BCA
n=8 Participants
Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
|
TAK-648 Sequence CAB
n=8 Participants
Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 8.26 • n=5 Participants
|
35.3 years
STANDARD_DEVIATION 11.00 • n=7 Participants
|
34.4 years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 9.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
3 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Height
|
175.6 cm
STANDARD_DEVIATION 13.22 • n=5 Participants
|
163.4 cm
STANDARD_DEVIATION 11.07 • n=7 Participants
|
171.4 cm
STANDARD_DEVIATION 4.98 • n=5 Participants
|
170.1 cm
STANDARD_DEVIATION 11.18 • n=4 Participants
|
|
Weight
|
77.46 kg
STANDARD_DEVIATION 18.762 • n=5 Participants
|
70.11 kg
STANDARD_DEVIATION 9.447 • n=7 Participants
|
81.41 kg
STANDARD_DEVIATION 7.596 • n=5 Participants
|
76.33 kg
STANDARD_DEVIATION 13.219 • n=4 Participants
|
|
Body Mass Index
|
24.76 kg/m^2
STANDARD_DEVIATION 2.350 • n=5 Participants
|
26.24 kg/m^2
STANDARD_DEVIATION 2.349 • n=7 Participants
|
27.68 kg/m^2
STANDARD_DEVIATION 1.709 • n=5 Participants
|
26.23 kg/m^2
STANDARD_DEVIATION 2.393 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each PeriodPopulation: The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.
Outcome measures
| Measure |
TAK-648 Regimen A
n=23 Participants
TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen B
n=23 Participants
Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen C
n=23 Participants
Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for TAK-648
|
4.504 mg/mL
Standard Deviation 1.2363
|
4.707 mg/mL
Standard Deviation 1.5255
|
5.185 mg/mL
Standard Deviation 1.9749
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each PeriodPopulation: The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.
Outcome measures
| Measure |
TAK-648 Regimen A
n=23 Participants
TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen B
n=23 Participants
Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen C
n=23 Participants
Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648
|
34.855 ng*hr/mL
Standard Deviation 8.8481
|
34.526 ng*hr/mL
Standard Deviation 9.2767
|
34.916 ng*hr/mL
Standard Deviation 10.7221
|
PRIMARY outcome
Timeframe: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each PeriodPopulation: The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.
Outcome measures
| Measure |
TAK-648 Regimen A
n=23 Participants
TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen B
n=23 Participants
Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen C
n=23 Participants
Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
|---|---|---|---|
|
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648
|
35.241 ng*hr/mL
Standard Deviation 8.9283
|
34.922 ng*hr/mL
Standard Deviation 9.3106
|
35.353 ng*hr/mL
Standard Deviation 10.7619
|
SECONDARY outcome
Timeframe: First dose of study drug to 30 days after the last dose of study drug (Up to Day 47)Population: Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
TAK-648 Regimen A
n=23 Participants
TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen B
n=23 Participants
Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen C
n=23 Participants
Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
|---|---|---|---|
|
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
17.4 percentage of participants
|
8.7 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)Population: Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.
Outcome measures
| Measure |
TAK-648 Regimen A
n=23 Participants
TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen B
n=23 Participants
Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen C
n=23 Participants
Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
|---|---|---|---|
|
Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose
|
4.3 percentage of participants
|
4.3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)Population: Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.
Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (beats per minute \[bpm\]).
Outcome measures
| Measure |
TAK-648 Regimen A
n=23 Participants
TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen B
n=23 Participants
Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen C
n=23 Participants
Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
|---|---|---|---|
|
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose
|
39.1 percentage of participants
|
47.8 percentage of participants
|
60.9 percentage of participants
|
Adverse Events
TAK-648 Regimen A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TAK-648 Regimen B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TAK-648 Regimen C
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-648 Regimen A
n=23 participants at risk
TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen B
n=23 participants at risk
Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
TAK-648 Regimen C
n=23 participants at risk
Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
|
|---|---|---|---|
|
Investigations
Blood creatine phosphokinase increased
|
4.3%
1/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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.
|
4.3%
1/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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%
0/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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
Abdominal pain
|
4.3%
1/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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.
|
4.3%
1/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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%
0/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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.
|
4.3%
1/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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%
0/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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
|
4.3%
1/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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%
0/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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%
0/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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.
|
|
Investigations
Heart rate irregular
|
4.3%
1/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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%
0/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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%
0/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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.
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.3%
1/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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%
0/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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%
0/23 • First dose of study drug to 30 days after last dose (Up to Day 47)
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